Nifedipine
- Product NDC
- 0904-7081
- 11-digit product format
- 009047081
- Labeler code
- 0904
- Product ID
- 0904-7081_af49dd32-02ac-47ab-b513-ca480fe8dc36
- 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
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nifedipine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NIFEDIPINE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9ZF7L6G2L |
| Rxcui | 1812011, 1812013, 1812015 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7081-06 | Nifedipine | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 6 |
| 0904-7081-06 | Nifedipine | 50 in 1 CARTON | TABLET, EXTENDED RELEASE | 50 | | 6 |
| 0904-7081-61 | Nifedipine | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | | 6 |
| 0904-7081-61 | 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 |
|---|
| 0904-7081 | NIFEDIPINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241108_41aa6fbd-96c1-40f7-92d4-cfdd2d5325e9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-7081-06 | 00904708106 | 50 BLISTER PACK in 1 CARTON (0904-7081-06) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 50 blister pack | 2019-03-12 | 0000-00-00 | No | No | Current |
| 0904-7081-61 | 00904708161 | 100 BLISTER PACK in 1 CARTON (0904-7081-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2019-03-12 | 0000-00-00 | No | No | Current |