Nifedipine
- Product NDC
- 46708-733
- 11-digit product format
- 467080733
- Labeler code
- 46708
- Product ID
- 46708-733_1486f187-0ec6-4c70-8991-02c1493912b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nifedipine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA216896
- Marketing category
- ANDA
- Marketing start
- 2022-11-23
- 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
- 2026-12-31
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 |
|---|
| 46708-733-31 | Nifedipine | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
| 46708-733-63 | Nifedipine | 300 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 300 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-733 | NIFEDIPINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, Legacy NDC, 2 package rows | 20221206_1486f187-0ec6-4c70-8991-02c1493912b4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-733-31 | 46708073331 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-733-31) | 2022-11-23 | 0000-00-00 | No | No | Current |
| 46708-733-63 | 46708073363 | 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-733-63) | 2022-11-23 | 0000-00-00 | No | No | Current |