Nifedipine
Nifedipine Extended-Release Tablets, USP 90 mg
Approved
Approval ID
36b07283-fc0e-4a14-b78f-1d2ab80e7f31
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2018
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nifedipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71610-055
Application NumberANDA076070
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2018
FDA Product Classification
INGREDIENTS (14)
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
nifedipineActive
Quantity: 90 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
hydroxyethyl cellulose (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C Yellow No. 5Inactive
Code: I753WB2F1M
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT