Ranitidine Hydrochloride
Ranitidine Hydrochloride Capsules, 150 mg and 300 mg
Approved
Approval ID
7bf94bf7-fa11-70be-9f65-fe26a3db5a63
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2018
Manufacturers
FDA
Dr. Reddy's Laboratories Limited
DUNS: 650562841
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ranitidine Hydrochloride
PRODUCT DETAILS
NDC Product Code55111-130
Application NumberANDA075742
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 21, 2018
Generic NameRanitidine Hydrochloride
INGREDIENTS (9)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
Ranitidine hydrochlorideActive
Quantity: 300 mg in 1 1
Code: BK76465IHM
Classification: ACTIM
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
Ranitidine Hydrochloride
PRODUCT DETAILS
NDC Product Code55111-129
Application NumberANDA075742
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 21, 2018
Generic NameRanitidine Hydrochloride
INGREDIENTS (9)
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
Ranitidine hydrochlorideActive
Quantity: 150 mg in 1 1
Code: BK76465IHM
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT