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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-967
Application NumberANDA077824
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ranitidine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2014
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-971
Application NumberANDA077824
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ranitidine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2014
FDA Product Classification
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