Nifedipine
- Product NDC
- 0378-0481
- 11-digit product format
- 003780481
- Labeler code
- 0378
- Product ID
- 0378-0481_b154bdb7-f761-491f-9a9c-14d23e9a1b52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nifedipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA090649
- Marketing category
- ANDA
- Marketing start
- 2000-03-14
- Marketing end
- 2019-11-30
- Substance
- NIFEDIPINE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NIFEDIPINE | ACTIVE INGREDIENT | I9ZF7L6G2L | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| NIFEDIPINE | ACTIVE MOIETY | I9ZF7L6G2L | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| CELLULOSE ACETATE | INACTIVE INGREDIENT | 3J2P07GVB6 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
DailyMed RxNorm Mappings#