Nifedipine
- Product NDC
- 67877-756
- 11-digit product format
- 678770756
- Labeler code
- 67877
- Product ID
- 67877-756_2833cb85-4017-41e2-aa4a-c19371ba85e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nifedipine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA216067
- Marketing category
- ANDA
- Marketing start
- 2022-03-30
- Substance
- NIFEDIPINE
- Active strength
- 90 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 | 90 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 |
|---|
| 67877-756-01 | Nifedipine | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 10 |
| 67877-756-05 | Nifedipine | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 10 |
| 67877-756-58 | Nifedipine | 300 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 300 | | 10 |
| 67877-756-90 | Nifedipine | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-756 | NIFEDIPINE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20230523_f661c1d9-f0f6-4595-82dd-f656bff974f1.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 |
|---|
| 67877-756-01 | 67877075601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-756-01) | 2022-03-30 | 0000-00-00 | No | No | Current |
| 67877-756-05 | 67877075605 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-756-05) | 2022-03-30 | 0000-00-00 | No | No | Current |
| 67877-756-58 | 67877075658 | 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-756-58) | 2022-12-30 | | No | No | Current |
| 67877-756-90 | 67877075690 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-756-90) | 2022-03-30 | 0000-00-00 | No | No | Current |