nifedipine
NIFEDIPINE Extended Release Tablets 30 mg, 60 mg, and 90 mg
Approved
Approval ID
60b85eab-17ad-4482-87d6-ca9720ca06e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4875
Application NumberNDA019684
Product Classification
M
Marketing Category
C73605
G
Generic Name
nifedipine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2012
FDA Product Classification
INGREDIENTS (9)
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
nifedipineActive
Quantity: 90 mg in 1 1
Code: I9ZF7L6G2L
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose acetateInactive
Code: 3J2P07GVB6
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT