Vancomycin Oral Capsule

Brand(s)
Vancocin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Anip Acquisition Company (2015-10-26)
Oldest Current Product
1986-04-15
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\VANCOMYCIN
FDAOB
ORAL\CAPSULE\VANCOMYCIN HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\VANCOMYCIN HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\VANCOMYCIN

product(s) by strength(s)

vancomycin 125 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1625590310VancocinNDAAnip Acquisition Company2014-11-17VANCOMYCIN HYDROCHLORIDEORALCAPSULENDA050606a078d9c2-f89c-4f9f-8ded-60ffb2983c3f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913560ANDAWatson Laboratories, Inc.2012-04-09VANCOMYCIN HYDROCHLORIDEORALCAPSULEANDA065510f04711a7-652e-427d-a7f5-65d4a1c3cae4
2174780741ANDAAkorn2012-04-09VANCOMYCIN HYDROCHLORIDEORALCAPSULEANDA0654780e7ead22-9618-418f-85a1-4d5ed0949f78
3477810729ANDAAlvogen, Inc.2012-04-09VANCOMYCIN HYDROCHLORIDEORALCAPSULEANDA06549029785dd0-f94f-48b5-9194-b4a796c464ce
4625590390NDA AUTHORIZED GENERICAnip Acquisition Company2015-10-26VANCOMYCIN HYDROCHLORIDEORALCAPSULENDA0506063707ad2e-5c82-4111-a370-e518e5e7e4c5
5633230338ANDAApp Pharmaceuticals, Llc2012-06-18VANCOMYCIN HYDROCHLORIDEORALCAPSULEANDA06545351e02383-2ba7-4ee4-bbc1-19c174d2ec0f, c8d63431-46d0-407b-b350-bb8e57e34f65
6669930210NDA AUTHORIZED GENERICPrasco Laboratories2012-04-10VANCOMYCIN HYDROCHLORIDEORALCAPSULENDA050606dc61c457-0ebe-4cd1-85ac-2830a1b09784
7681800166ANDALupin Pharmaceuticals, Inc.2015-03-27VANCOMYCIN HYDROCHLORIDEORALCAPSULEANDA09043920a8f14c-9c90-47f7-98b1-e8c63414cdf0

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544650VancocinNDACardinal Health1986-04-15VANCOMYCIN HYDROCHLORIDEORALCAPSULE665933125NDA05060617b69d90-d955-4403-84e5-1465379d961c

vancomycin 250 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1625590311VancocinNDAAnip Acquisition Company2014-11-17VANCOMYCIN HYDROCHLORIDEORALCAPSULENDA050606a078d9c2-f89c-4f9f-8ded-60ffb2983c3f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913561ANDAWatson Laboratories, Inc.2012-04-09VANCOMYCIN HYDROCHLORIDEORALCAPSULEANDA065510f04711a7-652e-427d-a7f5-65d4a1c3cae4
2174780742ANDAAkorn2012-04-09VANCOMYCIN HYDROCHLORIDEORALCAPSULEANDA0654780e7ead22-9618-418f-85a1-4d5ed0949f78
3477810730ANDAAlvogen, Inc.2012-04-09VANCOMYCIN HYDROCHLORIDEORALCAPSULEANDA06549029785dd0-f94f-48b5-9194-b4a796c464ce
4625590391NDA AUTHORIZED GENERICAnip Acquisition Company2015-10-26VANCOMYCIN HYDROCHLORIDEORALCAPSULENDA0506063707ad2e-5c82-4111-a370-e518e5e7e4c5
5633230339ANDAApp Pharmaceuticals, Llc2012-06-18VANCOMYCIN HYDROCHLORIDEORALCAPSULEANDA06545351e02383-2ba7-4ee4-bbc1-19c174d2ec0f, c8d63431-46d0-407b-b350-bb8e57e34f65
6669930211NDA AUTHORIZED GENERICPrasco Laboratories2012-04-10VANCOMYCIN HYDROCHLORIDEORALCAPSULENDA050606dc61c457-0ebe-4cd1-85ac-2830a1b09784

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544651VancocinNDACardinal Health1986-04-15VANCOMYCIN HYDROCHLORIDEORALCAPSULE665933126NDA05060617b69d90-d955-4403-84e5-1465379d961c

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA065453VANCOMYCIN HYDROCHLORIDEFRESENIUS KABI USA LLC2012-06-18ANDA065453_001, ANDA065453_002
2ANDA065478VANCOMYCIN HYDROCHLORIDEAKORN INC2012-04-09ANDA065478_001, ANDA065478_002
3ANDA065490VANCOMYCIN HYDROCHLORIDESTRIDES PHARMA GLOBAL PTE LTD2012-04-09ANDA065490_001, ANDA065490_002
4ANDA065510VANCOMYCIN HYDROCHLORIDEWATSON LABORATORIES INC2012-04-09ANDA065510_001, ANDA065510_002
5ANDA090439VANCOMYCIN HYDROCHLORIDELUPIN LTD2015-01-28ANDA090439_001, ANDA090439_002
6NDA050606VANCOCIN HYDROCHLORIDEANI PHARMACEUTICALS INC1986-04-15NDA050606_001, NDA050606_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065453_001RXVANCOMYCIN HYDROCHLORIDE (EQ 125MG BASE)ORALCAPSULEFalseAB2012-06-18VANCOMYCIN HYDROCHLORIDE
2ANDA065453_002RXVANCOMYCIN HYDROCHLORIDE (EQ 250MG BASE)ORALCAPSULEFalseAB2012-06-18VANCOMYCIN HYDROCHLORIDE
3ANDA065478_001RXVANCOMYCIN HYDROCHLORIDE (EQ 125MG BASE)ORALCAPSULEFalseAB2012-04-09VANCOMYCIN HYDROCHLORIDE
4ANDA065478_002RXVANCOMYCIN HYDROCHLORIDE (EQ 250MG BASE)ORALCAPSULEFalseAB2012-04-09VANCOMYCIN HYDROCHLORIDE
5ANDA065490_001RXVANCOMYCIN HYDROCHLORIDE (EQ 125MG BASE)ORALCAPSULEFalseAB2012-04-09VANCOMYCIN HYDROCHLORIDE
6ANDA065490_002RXVANCOMYCIN HYDROCHLORIDE (EQ 250MG BASE)ORALCAPSULEFalseAB2012-04-09VANCOMYCIN HYDROCHLORIDE
7ANDA065510_001RXVANCOMYCIN HYDROCHLORIDE (EQ 125MG BASE)ORALCAPSULEFalseAB2012-04-09VANCOMYCIN HYDROCHLORIDE
8ANDA065510_002RXVANCOMYCIN HYDROCHLORIDE (EQ 250MG BASE)ORALCAPSULEFalseAB2012-04-09VANCOMYCIN HYDROCHLORIDE
9ANDA090439_001RXVANCOMYCIN HYDROCHLORIDE (EQ 125MG BASE)ORALCAPSULEFalseAB2015-01-28VANCOMYCIN HYDROCHLORIDE
10ANDA090439_002RXVANCOMYCIN HYDROCHLORIDE (EQ 250MG BASE)ORALCAPSULEFalseAB2015-01-28VANCOMYCIN HYDROCHLORIDE
11NDA050606_001RXVANCOMYCIN HYDROCHLORIDE (EQ 125MG BASE)ORALCAPSULEFalseAB1986-04-15VANCOCIN HYDROCHLORIDE
12NDA050606_002RXVANCOMYCIN HYDROCHLORIDE (EQ 250MG BASE)ORALCAPSULETrueAB1986-04-15VANCOCIN HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10e7ead22-9618-418f-85a1-4d5ed0949f78 (view SPL)These highlights do not include all the information needed to use Vancomycin Hydrochloride Capsules, safely and effectively. See full prescribing information for Vancomycin Hydrochloride Capsules.Vancomycin Hydrochloride Capsules, USPInitial U.S. Approval: 1986prescriptionHuman PrescriptionAkorn2013-01-317174780741, 174780742
217b69d90-d955-4403-84e5-1465379d961c (view SPL)VANCOCIN HCl CAPSULES (vancomycin hydrochloride capsules, USP)prescriptionHuman PrescriptionCardinal HealthREPACK2011-06-071551544650, 551544651
320a8f14c-9c90-47f7-98b1-e8c63414cdf0 (view SPL)These highlights do not include all the information needed to use vancomycin hydrochloride capsules USP safely and effectively. See full prescribing information for vancomycin hydrochloride capsules USP. VANCOMYCIN Hydrochloride Capsules USP for Oral Use Initial U.S. Approval: 1986To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2015-02-013681800166
429785dd0-f94f-48b5-9194-b4a796c464ce (view SPL)These highlights do not include all the information needed to use vancomycin hydrochloride capsules, USP safely and effectively. See full prescribing information for vancomycin hydrochloride capsules, USP. Vancomycin Hydrochloride Capsules, USP Initial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules, USP and other antibacterial drugs, vancomycin hydrochloride capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionAlvogen, Inc.analysis, manufacture, pack2012-04-124477810729, 477810730
53707ad2e-5c82-4111-a370-e518e5e7e4c5 (view SPL)These highlights do not include all the information needed to use Vancomycin Hydrochloride Capsules USP safely and effectively. See full prescribing information for Vancomycin Hydrochloride Capsules USP. Vancomycin Hydrochloride Capsules USPInitial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsules and other antibacterial drugs, Vancomycin Hydrochloride Capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionAnip Acquisition CompanyLABEL, MANUFACTURE, PACK2015-10-261625590390, 625590391
651e02383-2ba7-4ee4-bbc1-19c174d2ec0f (view SPL)These highlights do not include all the information needed to use Vancomycin Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Vancomycin Hydrochloride Capsules, USP. Vancomycin Hydrochloride Capsules, USP Initial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-04-201633230338, 633230339
7a078d9c2-f89c-4f9f-8ded-60ffb2983c3f (view SPL)These highlights do not include all the information needed to use VANCOCIN CAPSULES safely and effectively. See full prescribing information for VANCOCIN CAPSULES. VANCOCIN (vancomycin hydrochloride USP) CAPSULESInitial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of VANCOCIN CAPSULES and other antibacterial drugs, VANCOCIN CAPSULES should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionAnip Acquisition CompanyLABEL, MANUFACTURE, PACK2014-11-171625590310, 625590311
8b7f386c7-8b78-4751-b6ae-e171925c2d54 (view SPL)These highlights do not include all the information needed to use VANCOCIN CAPSULES safely and effectively. See full prescribing information for VANCOCIN CAPSULES. VANCOCIN (vancomycin hydrochloride, USP) CAPSULESInitial U.S. Approval: 1986prescriptionHuman PrescriptionViropharmaAPI MANUFACTURE, MANUFACTURE2011-12-139665933125, 665933126
9c8d63431-46d0-407b-b350-bb8e57e34f65 (view SPL)These highlights do not include all the information needed to use Vancomycin Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Vancomycin Hydrochloride Capsules, USP. Vancomycin Hydrochloride Capsules, USP Initial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-06-251633230338, 633230339
10dc61c457-0ebe-4cd1-85ac-2830a1b09784 (view SPL)These highlights do not include all the information needed to use Vancomycin Hydrochloride Capsules USP safely and effectively. See full prescribing information for Vancomycin Hydrochloride Capsules USP. Vancomycin Hydrochloride Capsules USPInitial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsules and other antibacterial drugs, Vancomycin Hydrochloride Capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionPrasco LaboratoriesLABEL, MANUFACTURE, PACK2015-01-235669930210, 669930211
11f04711a7-652e-427d-a7f5-65d4a1c3cae4 (view SPL)These highlights do not include all the information needed to use vancomycin hydrochloride capsules, USP safely and effectively. See full prescribing information for vancomycin hydrochloride capsules, USP. VANCOMYCIN hydrochloride capsules, USP Initial U.S. Approval: 1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules, USP and other antibacterial drugs, vancomycin hydrochloride capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.prescriptionHuman PrescriptionWatson Laboratories, Inc.MANUFACTURE2012-04-106005913560, 005913561

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