Metoclopramide Injectable Solution

Brand(s)
Reglan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-11-11)
Oldest Current Product
1991-01-17
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\METOCLOPRAMIDE
FDAOB
INJECTION\INJECTION\METOCLOPRAMIDE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\METOCLOPRAMIDE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\METOCLOPRAMIDE HYDROCHLORIDE
INTRAVENOUS\INJECTION\METOCLOPRAMIDE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\METOCLOPRAMIDE
INTRAMUSCULAR\INJECTION\METOCLOPRAMIDE
INTRAVENOUS\INJECTION\METOCLOPRAMIDE

product(s) by strength(s)

metoclopramide 5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093414ANDAHospira, Inc.1991-01-17METOCLOPRAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA073118373ba08b-33ad-49fc-28a7-928e89a65314
2007034502ANDATeva Parenteral Medicines, Inc1991-12-01, 2015-08-17METOCLOPRAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0731355645a752-8868-4b51-8b59-48bb4276d763, cccf04bd-7463-40b8-a41f-cb1093c358d7, f18e7463-4497-4d0a-a6f9-c272cba6600c
3231550240ANDAHeritage Pharmaceuticals Inc.2014-01-03METOCLOPRAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA20475650a3cf38-66dc-4fa5-8a45-adf959c987ab

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840414ANDAGeneral Injecatables & Vaccines, Inc2010-05-01METOCLOPRAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004093414ANDA073118b78499dc-4d24-4226-be97-dc618d9da0cf
2525840450NDAGeneral Injecatables & Vaccines, Inc2010-08-01METOCLOPRAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION100190450NDA017862e2857ea0-df36-4d91-a705-a574fa323b2e
3525840451ReglanNDAGeneral Injecatables & Vaccines, Inc2010-08-01METOCLOPRAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION609770451NDA0178625498f6aa-f4c1-49a3-b969-0711077dde81
4551540450ANDACardinal Health1993-12-10METOCLOPRAMIDE HYDROCHLORIDEINTRAVENOUSINJECTION007034502ANDA0731351ecab710-8b7d-4903-80a8-de66562be55a
5551540452NDACardinal Health2010-12-09METOCLOPRAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION100190450NDA017862bfbc4b74-509b-4df8-be2b-d665c6a070af
6551542353ANDACardinal Health2009-09-22METOCLOPRAMIDE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004093414ANDA073118917494a9-cff1-4ee6-9523-e112120373c5

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070293METOCLOPRAMIDE HYDROCHLORIDETrueLYPHOMED DIV FUJISAWA USA INC1986-01-24ANDA070293_001Metoclopramide Prefilled Syringe
2ANDA070505METOCLOPRAMIDE HYDROCHLORIDETrueHOSPIRA INC1989-06-23ANDA070505_001Metoclopramide Prefilled Syringe
3ANDA070506METOCLOPRAMIDE HYDROCHLORIDETrueHOSPIRA INC1989-06-22ANDA070506_001Metoclopramide Prefilled Syringe
4ANDA070622METOCLOPRAMIDE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1987-03-02ANDA070622_001Metoclopramide Prefilled Syringe
5ANDA070623METOCLOPRAMIDE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1987-03-02ANDA070623_001Metoclopramide Prefilled Syringe
6ANDA070847METOCLOPRAMIDE HYDROCHLORIDETrueHOSPIRA INC1988-11-07ANDA070847_001Metoclopramide Prefilled Syringe
7ANDA070892METOCLOPRAMIDE HYDROCHLORIDETrueNORBROOK LABORATORIES LTD1988-08-26ANDA070892_001Metoclopramide Prefilled Syringe
8ANDA071291METOCLOPRAMIDE HYDROCHLORIDETrueHOSPIRA INC1989-03-03ANDA071291_001Metoclopramide Prefilled Syringe
9ANDA071990METOCLOPRAMIDE HYDROCHLORIDETrueHOSPIRA INC1989-01-18ANDA071990_001Metoclopramide Prefilled Syringe
10ANDA072155METOCLOPRAMIDE HYDROCHLORIDETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1992-03-30ANDA072155_001Metoclopramide Prefilled Syringe
11ANDA072244METOCLOPRAMIDE HYDROCHLORIDETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1992-03-30ANDA072244_001Metoclopramide Prefilled Syringe
12ANDA072247METOCLOPRAMIDE HYDROCHLORIDETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1992-05-18ANDA072247_001Metoclopramide Prefilled Syringe
13ANDA073117METOCLOPRAMIDE HYDROCHLORIDETrueHOSPIRA WORLDWIDE, INC1991-01-17ANDA073117_001Metoclopramide Prefilled Syringe
14ANDA073118METOCLOPRAMIDE HYDROCHLORIDEHOSPIRA INC1991-01-17ANDA073118_001Metoclopramide Prefilled Syringe
15ANDA073135METOCLOPRAMIDE HYDROCHLORIDETEVA PHARMACEUTICALS USA1991-11-27ANDA073135_001Metoclopramide Prefilled Syringe
16ANDA074147METOCLOPRAMIDE HYDROCHLORIDETrueHOSPIRA INC1996-08-02ANDA074147_001Metoclopramide Prefilled Syringe
17ANDA091392METOCLOPRAMIDE HYDROCHLORIDEBD RX INC2013-04-19ANDA091392_001Metoclopramide Prefilled Syringe
18ANDA204756METOCLOPRAMIDEEMCURE PHARMACEUTICALS LTD2013-12-20ANDA204756_001Metoclopramide Prefilled Syringe
19NDA017862REGLANBAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARENDA017862_001, NDA017862_004Metoclopramide Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070293_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 10MG BASE/2ML)INJECTIONFalse1986-01-24METOCLOPRAMIDE HYDROCHLORIDE
2ANDA070505_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1989-06-23METOCLOPRAMIDE HYDROCHLORIDE
3ANDA070506_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1989-06-22METOCLOPRAMIDE HYDROCHLORIDE
4ANDA070622_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 10MG BASE/2ML)INJECTIONFalse1987-03-02METOCLOPRAMIDE HYDROCHLORIDE
5ANDA070623_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1987-03-02METOCLOPRAMIDE HYDROCHLORIDE
6ANDA070847_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1988-11-07METOCLOPRAMIDE HYDROCHLORIDE
7ANDA070892_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 10MG BASE/2ML)INJECTIONFalse1988-08-26METOCLOPRAMIDE HYDROCHLORIDE
8ANDA071291_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1989-03-03METOCLOPRAMIDE HYDROCHLORIDE
9ANDA071990_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1989-01-18METOCLOPRAMIDE HYDROCHLORIDE
10ANDA072155_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1992-03-30METOCLOPRAMIDE HYDROCHLORIDE
11ANDA072244_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1992-03-30METOCLOPRAMIDE HYDROCHLORIDE
12ANDA072247_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1992-05-18METOCLOPRAMIDE HYDROCHLORIDE
13ANDA073117_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1991-01-17METOCLOPRAMIDE HYDROCHLORIDE
14ANDA073118_001RXMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP1991-01-17METOCLOPRAMIDE HYDROCHLORIDE
15ANDA073135_001RXMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP1991-11-27METOCLOPRAMIDE HYDROCHLORIDE
16ANDA074147_001discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalse1996-08-02METOCLOPRAMIDE HYDROCHLORIDE
17ANDA091392_001RXMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2013-04-19METOCLOPRAMIDE HYDROCHLORIDE
18ANDA204756_001RXMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2013-12-20METOCLOPRAMIDE
19NDA017862_001RXMETOCLOPRAMIDE HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONTrueAPREGLAN
20NDA017862_004discontinuedMETOCLOPRAMIDE HYDROCHLORIDE (EQ 10MG BASE/ML)INJECTIONFalse1987-05-28REGLAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11ecab710-8b7d-4903-80a8-de66562be55a (view SPL)Metoclopramide Injection USP Package Insert 4502 Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2015-09-293551540450
2373ba08b-33ad-49fc-28a7-928e89a65314 (view SPL)MetoclopramideprescriptionHuman PrescriptionHospira, Inc.2015-11-1114004093414
350a3cf38-66dc-4fa5-8a45-adf959c987ab (view SPL)Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-01-034231550240
45498f6aa-f4c1-49a3-b969-0711077dde81 (view SPL)Raglan (metoclopramide) 5 mg/mL Injection, USP 30 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-231525840451
55645a752-8868-4b51-8b59-48bb4276d763 (view SPL)Metoclopramide Injection USP Package Insert 4502 Rx onlyprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2014-12-101007034502
6917494a9-cff1-4ee6-9523-e112120373c5 (view SPL)MetoclopramideprescriptionHuman PrescriptionCardinal HealthREPACK2015-09-286551542353
7b78499dc-4d24-4226-be97-dc618d9da0cf (view SPL)Metoclopramide Injection 5mg/ml 2ml SDVprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Increlabel2012-04-172525840414
8bfbc4b74-509b-4df8-be2b-d665c6a070af (view SPL)Metoclopramide Injection, USPRx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2012-08-012551540452
9cccf04bd-7463-40b8-a41f-cb1093c358d7 (view SPL)Metoclopramide Injection USP Package Insert 4502 Rx onlyprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2014-03-278007034502
10e2857ea0-df36-4d91-a705-a574fa323b2e (view SPL)Metoclopramide 10 mg/2 mL Injection, USP 2 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-261525840450
11f18e7463-4497-4d0a-a6f9-c272cba6600c (view SPL)Metoclopramide Injection USP 4502 Rx onlyprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-08-111007034502

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