Vancomycin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Heritage Pharmaceuticals Inc. (2015-10-28)
Oldest Current Product
1958-11-14
License(s)
NDA, ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\VANCOMYCIN
FDAOB
INJECTION\INJECTION\VANCOMYCIN HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\VANCOMYCIN HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\VANCOMYCIN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\VANCOMYCIN
INTRAVENOUS\INJECTION, SOLUTION\VANCOMYCIN

product(s) by strength(s)

vancomycin 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692599ANDAPfizer Labs2011-05-10VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091469a03e74b0-047f-4c55-8cdb-5296bf3ebfda
2000692601ANDAPfizer Labs2011-09-19VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0915542659588c-3068-48c9-be43-dd24689a7e99
3004096510ANDAHospira, Inc.2009-04-29VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06545537592c56-6679-48f4-169f-3a00c2ab114e
4231550220ANDAHeritage Pharmaceuticals Inc.2011-11-29VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA202464572e293f-7338-4c34-b678-f7c3462c7802
5250210158ANDASagent Pharmaceuticals2012-09-20VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA20083706dcfd36-942f-4752-86ad-4c5a6fc3e48f
6633230314ANDAApp Pharmaceuticals, Llc2004-11-30VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0626630713a847-a334-4b73-af22-343aa06621b9, d3147f2d-1a72-4923-874b-8fdee2be625e
7674570342ANDAMylan Institutional Llc2011-09-19VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091554ce139a51-0471-4c31-b456-2f889f18dd2b
8674570614ANDAMylan Institutional Llc2011-09-19VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091554a759b52d-48f8-4e8a-aaaf-e2f88298f617
9761260073ANDAAgila Specialties Private Limited2011-09-19VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0915541494d2fe-3818-45e1-adb1-adb5acc26e69
10761260290ANDAAgila Specialties Private Limited2011-07-02VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091469e612b73b-5316-49cc-bfe3-b31374b07b98

vancomycin 4 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096535ANDAHospira, Inc.1992-10-29VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0629332fd9de3f-a95f-451c-a687-d2e1306e53bf, 70c8f765-2bb3-4553-b39d-5874a7eda882

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551542350ANDACardinal Health2010-07-29VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION004096535ANDA062933b51bb864-da6a-40df-8940-ec4ded792e89
2551542385ANDACardinal Health2010-07-29VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION004096535ANDA062933e78bfa6d-d257-46a0-84a7-8d722c58830d

vancomycin 4.17 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330069UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2013-05-01VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION3821f66b-d297-43c7-ab8e-f44be49a9b3d

vancomycin 5 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003383552NDABaxter Healthcare Corporation1958-11-14VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA05067199e523d8-9bde-43cb-8434-497015e5dcbd
2003383580NDABaxter Healthcare Corporation1958-11-14VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA05067199e523d8-9bde-43cb-8434-497015e5dcbd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096534ANDAHospira, Inc.1992-10-29VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0629312fd9de3f-a95f-451c-a687-d2e1306e53bf, 70c8f765-2bb3-4553-b39d-5874a7eda882

vancomycin 50 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692587ANDAPfizer Labs2011-05-10VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0653970dc0459b-3d5c-45a8-85d4-ad4927b683ee
2000692589ANDAPfizer Labs2011-05-10VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0653970dc0459b-3d5c-45a8-85d4-ad4927b683ee
3000692590ANDAPfizer Labs2011-05-10VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0654321e46fd1c-cb3c-4160-80bb-ed37a5cd7483
4004094332ANDAHospira, Inc.1988-08-04VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA062911c9ea31ec-4c26-452f-b07b-c5f894212cd5, f2901045-904f-47bd-74a1-c561facd7f25
5004096509ANDAHospira, Inc.1990-12-21VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06307691c050cf-3b2d-48bc-7297-e8dc68225e5a, b01aaa02-8f1d-4b57-96a5-337503428af1
6004096533ANDAHospira, Inc.1988-08-04VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA062912c9ea31ec-4c26-452f-b07b-c5f894212cd5, f2901045-904f-47bd-74a1-c561facd7f25
7007813187ANDASandoz Inc2010-04-27VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA09025073ce6c76-7636-49e3-a912-02d56353e009
8007813188ANDASandoz Inc2010-04-27VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA09025073ce6c76-7636-49e3-a912-02d56353e009
9231550219ANDAHeritage Pharmaceuticals Inc.2011-11-25VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA2022746fb78a67-d10f-4563-af0c-7243b21e1c51
10233600151ANDAAkorn-Strides, Llc2008-12-31VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065397622b9406-1c06-4323-8ca2-873cb9112dd4
11233600153ANDAAkorn-Strides, Llc2008-12-31VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065432cad65674-4e33-460c-b861-d96f2550ecdd
12250210157ANDASagent Pharmaceuticals2012-09-20VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA20083706dcfd36-942f-4752-86ad-4c5a6fc3e48f
13633230221ANDAApp Pharmaceuticals, Llc2000-09-01VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0626630576803d-95de-4a48-806a-69ae3fcaf6b0, f604d399-fded-4f4f-8efe-af558ed07b9d
14633230284ANDAApp Pharmaceuticals, Llc2000-09-20VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0626630576803d-95de-4a48-806a-69ae3fcaf6b0, f604d399-fded-4f4f-8efe-af558ed07b9d
15633230295ANDAApp Pharmaceuticals, Llc2001-07-17VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0626630713a847-a334-4b73-af22-343aa06621b9, d3147f2d-1a72-4923-874b-8fdee2be625e
16674570222ANDAMylan Institutional Llc2008-06-30VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065401ff01d0cb-bb52-4ba4-9d16-e37e787b903d
17674570225ANDAMylan Institutional Llc2012-01-10VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065401ff01d0cb-bb52-4ba4-9d16-e37e787b903d
18674570339ANDAMylan Institutional Llc2008-12-31VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0653972dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf
19674570340ANDAMylan Institutional Llc2008-12-31VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0653972dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf
20674570341ANDAMylan Institutional Llc2008-12-31VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0654323843d0d7-f70a-4b29-9478-dfb45b02425e
21674570611ANDAMylan Institutional Llc2008-12-31VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065397a548402e-f9bd-4de2-a67a-535649a7cdfa
22674570612ANDAMylan Institutional Llc2008-12-31VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065397a548402e-f9bd-4de2-a67a-535649a7cdfa
23674570613ANDAMylan Institutional Llc2008-12-31VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065432d1e08b5b-7223-467d-9bc8-dd4a04ed64da

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950424ANDARebel Distributors Corp2008-12-31VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION233600151ANDA0653976e8f9e57-8376-4ce5-8ef0-50b3dd3e1168
2525840332ANDAGeneral Injecatables & Vaccines, Inc2010-09-01VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION004094332ANDA062911d9303631-4301-4704-b85f-7547e88c68df
3551542351ANDACardinal Health2010-07-29VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION004096534ANDA062931b51bb864-da6a-40df-8940-ec4ded792e89
4551542393ANDACardinal Health2010-06-04VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION004096533ANDA062912debeaebb-d03b-446a-ac7d-27d3184bf48b
5551542398ANDACardinal Health2010-06-04VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION004094332ANDA062911debeaebb-d03b-446a-ac7d-27d3184bf48b

vancomycin 6 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330071UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2012-05-25VANCOMYCIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONabfcb49a-c106-4902-9736-8f97e4e50088

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060180VANCOCIN HYDROCHLORIDETrueANI PHARMACEUTICALS INCANDA060180_001, ANDA060180_002
2ANDA062476VANCOCIN HYDROCHLORIDETrueANI PHARMACEUTICALS INC1984-03-15ANDA062476_001, ANDA062476_002
3ANDA062663VANCOMYCIN HYDROCHLORIDEFRESENIUS KABI USA LLC1987-03-17ANDA062663_001, ANDA062663_002, ANDA062663_003, ANDA062663_004
4ANDA062682VANCOLEDTrueEUROHEALTH INTERNATIONAL SARL1986-07-22ANDA062682_001, ANDA062682_002, ANDA062682_003, ANDA062682_004, ANDA062682_005
5ANDA062716VANCOCIN HYDROCHLORIDETrueANI PHARMACEUTICALS INC1987-03-13ANDA062716_001, ANDA062716_002
6ANDA062812VANCOCIN HYDROCHLORIDETrueANI PHARMACEUTICALS INC1987-11-17ANDA062812_001, ANDA062812_002, ANDA062812_003
7ANDA062879VANCOMYCIN HYDROCHLORIDETrueHIKMA MAPLE LTD1988-08-02ANDA062879_001, ANDA062879_002
8ANDA062911VANCOMYCIN HYDROCHLORIDEHOSPIRA INC1988-08-04ANDA062911_001
9ANDA062912VANCOMYCIN HYDROCHLORIDEHOSPIRA INC1988-08-04ANDA062912_001, ANDA062912_002
10ANDA062931VANCOMYCIN HYDROCHLORIDEHOSPIRA INC1992-10-29ANDA062931_001
11ANDA062933VANCOMYCIN HYDROCHLORIDEHOSPIRA INC1992-10-29ANDA062933_001, ANDA062933_002
12ANDA062956VANCORTruePHARMACIA AND UPJOHN CO1988-08-01ANDA062956_001, ANDA062956_002
13ANDA063076VANCOMYCIN HYDROCHLORIDEHOSPIRA INC1990-12-21ANDA063076_001
14ANDA065397VANCOMYCIN HYDROCHLORIDEMYLAN LABORATORIES LTD2008-12-30ANDA065397_001, ANDA065397_002
15ANDA065401VANCOMYCIN HYDROCHLORIDEMUSTAFA NEVZAT ILAC SANAYII AS (MN PHARMACEUTICALS)2008-06-30ANDA065401_001, ANDA065401_002
16ANDA065432VANCOMYCIN HYDROCHLORIDEMYLAN LABORATORIES LTD2008-12-30ANDA065432_001
17ANDA065455VANCOMYCIN HYDROCHLORIDEHOSPIRA INC2009-04-29ANDA065455_001
18ANDA090250VANCOMYCIN HYDROCHLORIDESANDOZ INC2010-04-27ANDA090250_001, ANDA090250_002
19ANDA091377VANCOMYCIN HYDROCHLORIDEXELLIA PHARMACEUTICALS APS2015-09-09ANDA091377_001, ANDA091377_002
20ANDA091469VANCOMYCIN HYDROCHLORIDEMYLAN LABORATORIES LTD2011-07-01ANDA091469_001
21ANDA091554VANCOMYCIN HYDROCHLORIDEMYLAN LABORATORIES LTD2011-09-19ANDA091554_001
22ANDA200837VANCOMYCIN HYDROCHLORIDESAGENT PHARMACEUTICALS INC2012-08-10ANDA200837_001, ANDA200837_002
23ANDA201048VANCOMYCIN HYDROCHLORIDESANDOZ INC2012-08-10ANDA201048_001, ANDA201048_002
24ANDA202274VANCOMYCIN HYDROCHLORIDEEMCURE PHARMACEUTICALS LTD2013-10-31ANDA202274_001
25ANDA202275VANCOMYCIN HYDROCHLORIDEEMCURE PHARMACEUTICALS LTD2013-10-31ANDA202275_001, ANDA202275_002
26ANDA202464VANCOMYCIN HYDROCHLORIDEEMCURE PHARMACEUTICALS LTD2013-10-09ANDA202464_001
27NDA050671VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1993-04-29NDA050671_001, NDA050671_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA060180_001discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalseVANCOCIN HYDROCHLORIDE
2ANDA060180_002discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalse1986-03-21VANCOCIN HYDROCHLORIDE
3ANDA062476_001discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalse1984-03-15VANCOCIN HYDROCHLORIDE
4ANDA062476_002discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalse1986-03-21VANCOCIN HYDROCHLORIDE
5ANDA062663_001RXVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONTrueAP1987-03-17VANCOMYCIN HYDROCHLORIDE
6ANDA062663_002RXVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONTrueAP1987-07-31VANCOMYCIN HYDROCHLORIDE
7ANDA062663_003RXVANCOMYCIN HYDROCHLORIDE (EQ 5GM BASE/VIAL)INJECTIONTrueAP1988-06-03VANCOMYCIN HYDROCHLORIDE
8ANDA062663_004RXVANCOMYCIN HYDROCHLORIDE (EQ 10GM BASE/VIAL)INJECTIONTrueAP1997-11-28VANCOMYCIN HYDROCHLORIDE
9ANDA062682_001discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalse1986-07-22VANCOLED
10ANDA062682_002discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalse1988-03-30VANCOLED
11ANDA062682_003discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalse1988-05-11VANCOLED
12ANDA062682_004discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 5GM BASE/VIAL)INJECTIONFalse1988-05-11VANCOLED
13ANDA062682_005discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 10GM BASE/VIAL)INJECTIONFalse1988-05-11VANCOLED
14ANDA062716_001discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalse1987-03-13VANCOCIN HYDROCHLORIDE
15ANDA062716_002discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalse1987-03-13VANCOCIN HYDROCHLORIDE
16ANDA062812_001discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalse1987-11-17VANCOCIN HYDROCHLORIDE
17ANDA062812_002discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalse1987-11-17VANCOCIN HYDROCHLORIDE
18ANDA062812_003discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 10GM BASE/VIAL)INJECTIONFalse1987-11-17VANCOCIN HYDROCHLORIDE
19ANDA062879_001discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalse1988-08-02VANCOMYCIN HYDROCHLORIDE
20ANDA062879_002discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalse1988-08-02VANCOMYCIN HYDROCHLORIDE
21ANDA062911_001RXVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONTrueAP1988-08-04VANCOMYCIN HYDROCHLORIDE
22ANDA062912_001RXVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONTrueAP1988-08-04VANCOMYCIN HYDROCHLORIDE
23ANDA062912_002RXVANCOMYCIN HYDROCHLORIDE (EQ 750MG BASE/VIAL)INJECTIONTrueAP2009-01-07VANCOMYCIN HYDROCHLORIDE
24ANDA062931_001RXVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONTrueAP1992-10-29VANCOMYCIN HYDROCHLORIDE
25ANDA062933_001RXVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONTrueAP1992-10-29VANCOMYCIN HYDROCHLORIDE
26ANDA062933_002RXVANCOMYCIN HYDROCHLORIDE (EQ 750MG BASE/VIAL)INJECTIONTrueAP2009-05-27VANCOMYCIN HYDROCHLORIDE
27ANDA062956_001discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalse1988-08-01VANCOR
28ANDA062956_002discontinuedVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalse1988-08-01VANCOR
29ANDA063076_001RXVANCOMYCIN HYDROCHLORIDE (EQ 5GM BASE/VIAL)INJECTIONTrueAP1990-12-21VANCOMYCIN HYDROCHLORIDE
30ANDA065397_001RXVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalseAP2008-12-30VANCOMYCIN HYDROCHLORIDE
31ANDA065397_002RXVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2008-12-30VANCOMYCIN HYDROCHLORIDE
32ANDA065401_001RXVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalseAP2008-06-30VANCOMYCIN HYDROCHLORIDE
33ANDA065401_002RXVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2008-06-30VANCOMYCIN HYDROCHLORIDE
34ANDA065432_001RXVANCOMYCIN HYDROCHLORIDE (EQ 5GM BASE/VIAL)INJECTIONFalseAP2008-12-30VANCOMYCIN HYDROCHLORIDE
35ANDA065455_001RXVANCOMYCIN HYDROCHLORIDE (EQ 10GM BASE/VIAL)INJECTIONFalseAP2009-04-29VANCOMYCIN HYDROCHLORIDE
36ANDA090250_001RXVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalseAP2010-04-27VANCOMYCIN HYDROCHLORIDE
37ANDA090250_002RXVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2010-04-27VANCOMYCIN HYDROCHLORIDE
38ANDA091377_001RXVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalseAP2015-09-09VANCOMYCIN HYDROCHLORIDE
39ANDA091377_002RXVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2015-09-09VANCOMYCIN HYDROCHLORIDE
40ANDA091469_001RXVANCOMYCIN HYDROCHLORIDE (EQ 10GM BASE/VIAL)INJECTIONFalseAP2011-07-01VANCOMYCIN HYDROCHLORIDE
41ANDA091554_001RXVANCOMYCIN HYDROCHLORIDE (EQ 10GM BASE/VIAL)INJECTIONFalseAP2011-09-19VANCOMYCIN HYDROCHLORIDE
42ANDA200837_001RXVANCOMYCIN HYDROCHLORIDE (EQ 5GM BASE/VIAL)INJECTIONFalseAP2012-08-10VANCOMYCIN HYDROCHLORIDE
43ANDA200837_002RXVANCOMYCIN HYDROCHLORIDE (EQ 10GM BASE/VIAL)INJECTIONFalseAP2014-09-02VANCOMYCIN HYDROCHLORIDE
44ANDA201048_001RXVANCOMYCIN HYDROCHLORIDE (EQ 5GM BASE/VIAL)INJECTIONFalseAP2012-08-10VANCOMYCIN HYDROCHLORIDE
45ANDA201048_002RXVANCOMYCIN HYDROCHLORIDE (EQ 10GM BASE/VIAL)INJECTIONFalseAP2012-08-10VANCOMYCIN HYDROCHLORIDE
46ANDA202274_001RXVANCOMYCIN HYDROCHLORIDE (EQ 5GM BASE/VIAL)INJECTIONFalseAP2013-10-31VANCOMYCIN HYDROCHLORIDE
47ANDA202275_001RXVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONFalseAP2013-10-31VANCOMYCIN HYDROCHLORIDE
48ANDA202275_002RXVANCOMYCIN HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2013-10-31VANCOMYCIN HYDROCHLORIDE
49ANDA202464_001RXVANCOMYCIN HYDROCHLORIDE (EQ 10GM BASE/VIAL)INJECTIONFalseAP2013-10-09VANCOMYCIN HYDROCHLORIDE
50NDA050671_001RXVANCOMYCIN HYDROCHLORIDE (EQ 500MG BASE/100ML)INJECTIONTrue1993-04-29VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER
51NDA050671_002RXVANCOMYCIN HYDROCHLORIDE (EQ 750MG BASE/150ML)INJECTIONTrue2010-12-20VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10576803d-95de-4a48-806a-69ae3fcaf6b0 (view SPL)VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-05-171633230221, 633230284
206dcfd36-942f-4752-86ad-4c5a6fc3e48f (view SPL)VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP(Formerly: Sterile Vancomycin Hydrochloride)(For Intravenous Use After Dilution)prescriptionHuman PrescriptionSagent Pharmaceuticals2014-10-227250210157, 250210158
30713a847-a334-4b73-af22-343aa06621b9 (view SPL)VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-08-101633230295, 633230314
40dc0459b-3d5c-45a8-85d4-ad4927b683ee (view SPL)STERILE VANCOMYCIN HYDROCHLORIDE, USPprescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2013-02-084000692587, 000692589
51494d2fe-3818-45e1-adb1-adb5acc26e69 (view SPL)VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP(Formerly: Sterile Vancomycin Hydrochloride)prescriptionHuman PrescriptionAgila Specialties Private Limited2012-11-293761260073
61e46fd1c-cb3c-4160-80bb-ed37a5cd7483 (view SPL)STERILE VANCOMYCIN HYDROCHLORIDE, USPprescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE, REPACK2011-09-144000692590
72659588c-3068-48c9-be43-dd24689a7e99 (view SPL)VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USPprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-11-201000692601
82dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf (view SPL)Vancomycin Hydrochloride for Injection, USPprescriptionHuman PrescriptionMylan Institutional LlcANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-02-032674570339, 674570340
92e93bb3a-43b4-4a37-9be2-1ba8be17aed0 (view SPL)Vancomycin HCl 1.5 g in 0.9% Sodium Chloride 300 mL BagprescriptionHuman PrescriptionCantrell Drug Companymanufacture2014-08-205525330070
102fd9de3f-a95f-451c-a687-d2e1306e53bf (view SPL)Vancomycin Hydrochloride for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-10-2618004096534, 004096535, 004096531
1137592c56-6679-48f4-169f-3a00c2ab114e (view SPL)Vancomycin Hydrochloride for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-10-2714004096510
123821f66b-d297-43c7-ab8e-f44be49a9b3d (view SPL)Vancomycin HCl 1.25 g in 0.9% Sodium Chloride 300 mL BagprescriptionHuman PrescriptionCantrell Drug Companymanufacture2014-08-207525330069
133843d0d7-f70a-4b29-9478-dfb45b02425e (view SPL)Vancomycin Hydrochloride for Injection, USP(Formerly: Sterile Vancomycin Hydrochloride)prescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2013-11-071674570341
144409aab0-0822-49b8-af30-98da91ce6033 (view SPL)Vancomycin HCl 1.25 g Added to 0.9% Sodium Chloride 250 mL BagprescriptionHuman PrescriptionCantrell Drug Companymanufacture2012-12-033525330070
15572e293f-7338-4c34-b678-f7c3462c7802 (view SPL)Vancomycin Hydrochloride for Injection, USPprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, manufacture2015-10-289231550220
16622b9406-1c06-4323-8ca2-873cb9112dd4 (view SPL)Sterile Vancomycin Hydrochloride USP 500 mg & 1 gprescriptionHuman PrescriptionAkorn-Strides, LlcAnalysis, Manufacture2010-08-181233600151
176e8f9e57-8376-4ce5-8ef0-50b3dd3e1168 (view SPL)Sterile Vancomycin Hydrochloride USP 500 mg & 1 gprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-221216950424
186fb78a67-d10f-4563-af0c-7243b21e1c51 (view SPL)Vancomycin Hydrochloride for Injection, USPprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-10-2810231550219
1970c8f765-2bb3-4553-b39d-5874a7eda882 (view SPL)Vancomycin Hydrochloride for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-05-021004096534, 004096535
2073ce6c76-7636-49e3-a912-02d56353e009 (view SPL)Vancomycin Hydrochloride for Injection, USP Fliptop Vial for Intravenous UseprescriptionHuman PrescriptionSandoz Inc2015-09-286007813187, 007813188
2191c050cf-3b2d-48bc-7297-e8dc68225e5a (view SPL)Vancomycin Hydrochloride for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-10-2717004096509
2299e523d8-9bde-43cb-8434-497015e5dcbd (view SPL)Vancomycin Injection, USPin GALAXY Plastic Container (PL 2040) For Intravenous Use OnlyprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-08-158003383552, 003383580, 003383551
23a03e74b0-047f-4c55-8cdb-5296bf3ebfda (view SPL)Vancomycin Hydrochloride for Injection, USPPharmacy Bulk Package Bottle 10 gramsANDA 91-469prescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE, PACK2013-02-123000692599
24a548402e-f9bd-4de2-a67a-535649a7cdfa (view SPL)Vancomycin Hydrochloride for Injection, USP (Formerly: Sterile Vancomycin Hydrochloride)prescriptionHuman PrescriptionMylan Institutional LlcANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-02-172674570611, 674570612
25a759b52d-48f8-4e8a-aaaf-e2f88298f617 (view SPL)prescriptionHuman PrescriptionMylan Institutional LlcANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-12-011674570614
26abfcb49a-c106-4902-9736-8f97e4e50088 (view SPL)Vancomycin HCl 1.5 g Added to 0.9% Sodium Chloride 250 mL BagprescriptionHuman PrescriptionCantrell Drug Company2012-12-033525330071
27b01aaa02-8f1d-4b57-96a5-337503428af1 (view SPL)Vancomycin Hydrochloride for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-04-291004096509
28b51bb864-da6a-40df-8940-ec4ded792e89 (view SPL)VancomycinprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-132551542350, 551542351
29c9ea31ec-4c26-452f-b07b-c5f894212cd5 (view SPL)Vancomycin Hydrochloride for Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-05-011004094332, 004096533
30cad65674-4e33-460c-b861-d96f2550ecdd (view SPL)Sterile Vancomycin Hydrochloride USP 5 gprescriptionHuman PrescriptionAkorn-Strides, LlcAnalysis, Manufacture, Repack2010-08-192233600153
31ce139a51-0471-4c31-b456-2f889f18dd2b (view SPL)VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP(Formerly: Sterile Vancomycin Hydrochloride)prescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2013-11-081674570342
32d1e08b5b-7223-467d-9bc8-dd4a04ed64da (view SPL)prescriptionHuman PrescriptionMylan Institutional LlcANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-11-191674570613
33d3147f2d-1a72-4923-874b-8fdee2be625e (view SPL)Vancomycin Hydrochloride for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-08-311633230295, 633230314
34d9303631-4301-4704-b85f-7547e88c68df (view SPL)Sterile Vancomycin Hydrochloride 500 mg USP Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-06-146525840332
35debeaebb-d03b-446a-ac7d-27d3184bf48b (view SPL)VancomycinRx only Hydrochloride for Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-01-158551542393, 551542398
36e612b73b-5316-49cc-bfe3-b31374b07b98 (view SPL)VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP(Formerly: Sterile Vancomycin Hydrochloride)prescriptionHuman PrescriptionAgila Specialties Private LimitedAnalysis, Label, Manufacture, Pack, Sterilize2014-08-221761260290
37e78bfa6d-d257-46a0-84a7-8d722c58830d (view SPL)VancomycinprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-131551542385
38f2901045-904f-47bd-74a1-c561facd7f25 (view SPL)Vancomycin Hydrochloride for Injection, USP Fliptop Vial For Intravenous UseprescriptionHuman PrescriptionHospira, Inc.2015-10-2317004094332, 004096533, 004096531
39f604d399-fded-4f4f-8efe-af558ed07b9d (view SPL)Vancomycin Hydrochloride for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-08-313633230221, 633230284
40ff01d0cb-bb52-4ba4-9d16-e37e787b903d (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2013-05-306674570222, 674570225

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII