nifedipine
Nifedipine Extended-Release Tablets, USP Rx only For Oral Use
Approved
Approval ID
c7874606-c71e-424c-b881-38697988e0d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
Products 2
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 Code68682-109
Application NumberANDA075289
Product Classification
M
Marketing Category
C73584
G
Generic Name
nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2019
FDA Product Classification
INGREDIENTS (15)
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
METHYL METHACRYLATEInactive
Code: 196OC77688
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
NIFEDIPINEActive
Quantity: 60 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
nifedipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-108
Application NumberANDA075289
Product Classification
M
Marketing Category
C73584
G
Generic Name
nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2019
FDA Product Classification
INGREDIENTS (15)
NIFEDIPINEActive
Quantity: 30 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYL METHACRYLATEInactive
Code: 196OC77688
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT