Ranitidine Injectable Solution

Brand(s)
Zantac
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Covis Pharmaceuticals, Inc. (2013-06-28)
Oldest Current Product
1989-10-01
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\RANITIDINE
FDAOB
INJECTION\INJECTION\RANITIDINE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\RANITIDINE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\RANITIDINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\RANITIDINE
INTRAMUSCULAR\INJECTION\RANITIDINE

product(s) by strength(s)

ranitidine 25 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1249870362ZantacNDACovis Pharmaceuticals, Inc.2013-03-15RANITIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA0190907159badb-315f-4d1d-804a-49624b168c31
2249870363ZantacNDACovis Pharmaceuticals, Inc.2013-06-14RANITIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA0190907159badb-315f-4d1d-804a-49624b168c31

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1658410763ANDACadila Healthcare Limited2013-03-01RANITIDINE HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA0915349268c1df-bcf3-4899-896d-044492802a33
2683820422ANDAZydus Pharmaceuticals (Usa) Inc.2013-03-01RANITIDINE HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA09153416acb43b-d982-484a-af3d-00ff4f2d5c5a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551541106ZantacNDACardinal Health1989-10-01RANITIDINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION001730362NDA019090d807c625-61b5-487c-b72a-8a1e55991571

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074764RANITIDINE HYDROCHLORIDETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2004-11-19ANDA074764_001
2ANDA074777RANITIDINE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2005-03-02ANDA074777_001
3ANDA077458RANITIDINE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2006-02-16ANDA077458_001
4ANDA091534RANITIDINE HYDROCHLORIDEZYDUS PHARMACEUTICALS USA INC2013-02-22ANDA091534_001
5NDA019090ZANTACCONCORDIA PHARMACEUTICALS INC1984-10-19NDA019090_001
6NDA019593ZANTAC IN PLASTIC CONTAINERTrueCOVIS INJECTABLES SARL1986-12-17NDA019593_001, NDA019593_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074764_001discontinuedRANITIDINE HYDROCHLORIDE (EQ 25MG BASE/ML)INJECTIONFalse2004-11-19RANITIDINE HYDROCHLORIDE
2ANDA074777_001RXRANITIDINE HYDROCHLORIDE (EQ 25MG BASE/ML)INJECTIONFalseAP2005-03-02RANITIDINE HYDROCHLORIDE
3ANDA077458_001RXRANITIDINE HYDROCHLORIDE (EQ 25MG BASE/ML)INJECTIONFalseAP2006-02-16RANITIDINE HYDROCHLORIDE
4ANDA091534_001RXRANITIDINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseAP2013-02-22RANITIDINE HYDROCHLORIDE
5NDA019090_001RXRANITIDINE HYDROCHLORIDE (EQ 25MG BASE/ML)INJECTIONTrueAP1984-10-19ZANTAC
6NDA019593_001discontinuedRANITIDINE HYDROCHLORIDE (EQ 50MG BASE/100ML)INJECTIONFalse1986-12-17ZANTAC IN PLASTIC CONTAINER
7NDA019593_002discontinuedRANITIDINE HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse1991-09-27ZANTAC IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
116acb43b-d982-484a-af3d-00ff4f2d5c5a (view SPL)Ranitidine Injection, USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2013-08-052683820422
27159badb-315f-4d1d-804a-49624b168c31 (view SPL)ZANTAC (ranitidine hydrochloride)InjectionprescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2013-06-284249870362, 249870363
39268c1df-bcf3-4899-896d-044492802a33 (view SPL)Ranitidine Injection, USPprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2013-08-052658410763
4d807c625-61b5-487c-b72a-8a1e55991571 (view SPL)ZANTAC (ranitidine hydrochloride)InjectionZANTAC (ranitidine hydrochloride)Injection PremixedprescriptionHuman PrescriptionCardinal HealthREPACK2012-08-022551541106
5da7dbbe1-4f2d-4466-9573-8d239d112998 (view SPL)ZANTAC (ranitidine hydrochloride)InjectionprescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2013-06-143249870364

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