Ranitidine
Ranitidine Tablets, USP
Approved
Approval ID
7f3348a9-ce69-48d6-89f4-5c0e7d38a255
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ranitidine
PRODUCT DETAILS
NDC Product Code43353-967
Application NumberANDA077824
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 1, 2014
Generic NameRanitidine
INGREDIENTS (10)
PolydextroseInactive
Code: VH2XOU12IE
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
D&c Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: BK76465IHM
Classification: ACTIM
Ranitidine
PRODUCT DETAILS
NDC Product Code43353-971
Application NumberANDA077824
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 1, 2014
Generic NameRanitidine
INGREDIENTS (10)
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
PolydextroseInactive
Code: VH2XOU12IE
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: BK76465IHM
Classification: ACTIM
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Fd&c Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT