Ranitidine Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2014-02-21)
Oldest Current Product
1997-10-22
License(s)
ANDA
RxNORM
ORAL CAPSULE\RANITIDINE
FDAOB
ORAL\CAPSULE\RANITIDINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\RANITIDINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\RANITIDINE

product(s) by strength(s)

ranitidine 150 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007812855ANDASandoz Inc1997-10-22RANITIDINE HYDROCHLORIDEORALCAPSULEANDA074655b0af5ca1-9189-4c62-bdf1-f1124ec337e7
2551110129ANDADr. Reddy'S Laboratories Ltd2001-01-12RANITIDINE HYDROCHLORIDEORALCAPSULEANDA0757427bf94bf7-fa11-70be-9f65-fe26a3db5a63

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151354ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1997-10-22RANITIDINE HYDROCHLORIDEORALCAPSULE007812855ANDA07465511508997-cbd1-4c4b-8861-56640f923eb1
2216950337ANDARebel Distributors Corp1997-10-22RANITIDINE HYDROCHLORIDEORALCAPSULE007812855ANDA074655b6c0ff30-03f5-4c1b-9077-f0918cf40a91

ranitidine 300 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007812865ANDASandoz Inc1997-10-22RANITIDINE HYDROCHLORIDEORALCAPSULEANDA074655b0af5ca1-9189-4c62-bdf1-f1124ec337e7
2551110130ANDADr. Reddy'S Laboratories Ltd2001-04-01RANITIDINE HYDROCHLORIDEORALCAPSULEANDA0757427bf94bf7-fa11-70be-9f65-fe26a3db5a63

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950338ANDARebel Distributors Corp1997-10-22RANITIDINE HYDROCHLORIDEORALCAPSULE007812865ANDA074655b6c0ff30-03f5-4c1b-9077-f0918cf40a91

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074655RANITIDINE HYDROCHLORIDESANDOZ INC1997-10-22ANDA074655_001, ANDA074655_002
2ANDA075557RANITIDINE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC2003-10-31ANDA075557_001, ANDA075557_002
3ANDA075564RANITIDINE HYDROCHLORIDETrueMYLAN PHARMACEUTICALS INC2000-10-27ANDA075564_001, ANDA075564_002
4ANDA075742RANITIDINE HYDROCHLORIDEDR REDDYS LABORATORIES LTD2000-11-29ANDA075742_001, ANDA075742_002
5NDA020095ZANTAC 150TrueGLAXOSMITHKLINE1994-03-08NDA020095_001, NDA020095_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074655_001RXRANITIDINE HYDROCHLORIDE (EQ 150MG BASE)ORALCAPSULEFalseAB1997-10-22RANITIDINE HYDROCHLORIDE
2ANDA074655_002RXRANITIDINE HYDROCHLORIDE (EQ 300MG BASE)ORALCAPSULETrueAB1997-10-22RANITIDINE HYDROCHLORIDE
3ANDA075557_001discontinuedRANITIDINE HYDROCHLORIDE (EQ 150MG BASE)ORALCAPSULEFalse2003-10-31RANITIDINE HYDROCHLORIDE
4ANDA075557_002discontinuedRANITIDINE HYDROCHLORIDE (EQ 300MG BASE)ORALCAPSULEFalse2003-10-31RANITIDINE HYDROCHLORIDE
5ANDA075564_001discontinuedRANITIDINE HYDROCHLORIDE (EQ 150MG BASE)ORALCAPSULEFalse2000-10-27RANITIDINE HYDROCHLORIDE
6ANDA075564_002discontinuedRANITIDINE HYDROCHLORIDE (EQ 300MG BASE)ORALCAPSULEFalse2000-10-27RANITIDINE HYDROCHLORIDE
7ANDA075742_001RXRANITIDINE HYDROCHLORIDE (EQ 150MG BASE)ORALCAPSULEFalseAB2000-11-29RANITIDINE HYDROCHLORIDE
8ANDA075742_002RXRANITIDINE HYDROCHLORIDE (EQ 300MG BASE)ORALCAPSULEFalseAB2000-11-29RANITIDINE HYDROCHLORIDE
9NDA020095_001discontinuedRANITIDINE HYDROCHLORIDE (EQ 150MG BASE)ORALCAPSULEFalse1994-03-08ZANTAC 150
10NDA020095_002discontinuedRANITIDINE HYDROCHLORIDE (EQ 300MG BASE)ORALCAPSULEFalse1994-03-08ZANTAC 150

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
111508997-cbd1-4c4b-8861-56640f923eb1 (view SPL)Ranitidine Tablets, USP and Ranitidine CapsulesprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-11-142006151354
27bf94bf7-fa11-70be-9f65-fe26a3db5a63 (view SPL)Ranitidine Hydrochloride Capsules, 150 mg and 300 mgprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2012-06-201551110129, 551110130
3b0af5ca1-9189-4c62-bdf1-f1124ec337e7 (view SPL)Ranitidine Tablets, USP and Ranitidine CapsulesprescriptionHuman PrescriptionSandoz Inc2014-02-2118007812855, 007812865, 007811883, 007811884Ranitidine Oral Tablet
4b6c0ff30-03f5-4c1b-9077-f0918cf40a91 (view SPL)Ranitidine Tablets, USP and Ranitidine CapsulesprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-11-111216950337, 216950338

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