Nifedipine
- Product NDC
- 0904-7080
- 11-digit product format
- 009047080
- Labeler code
- 0904
- Product ID
- 0904-7080_104876d9-0312-4f12-9324-76da4a8663a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nifedipine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA210614
- Marketing category
- ANDA
- Marketing start
- 2019-03-12
- Marketing end
- 2022-09-30
- Substance
- NIFEDIPINE
- Active strength
- 30 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7080-06 | Nifedipine | 50 in 1 CARTON | TABLET, EXTENDED RELEASE | 50 | | 6 |
| 0904-7080-06 | Nifedipine | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 6 |
| 0904-7080-61 | Nifedipine | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | | 6 |
| 0904-7080-61 | Nifedipine | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7080 | NIFEDIPINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 5 | Legacy NDC, 4 package rows | 20241108_41aa6fbd-96c1-40f7-92d4-cfdd2d5325e9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-7080-06 | 00904708006 | 50 BLISTER PACK in 1 CARTON (0904-7080-06) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 50 blister pack | 2019-03-12 | 2022-09-30 | No | No | Current |
| 0904-7080-61 | 00904708061 | 100 BLISTER PACK in 1 CARTON (0904-7080-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2019-03-12 | 2022-09-30 | No | No | Current |