Nifedipine
- Product NDC
- 68788-8164
- 11-digit product format
- 687888164
- Labeler code
- 68788
- Product ID
- 68788-8164_5c357886-29f3-40df-9dfb-eefcab465cc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nifedipine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA210614
- Marketing category
- ANDA
- Marketing start
- 2022-04-04
- 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 | 1812013 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8164-1 | Nifedipine | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 4 |
| 68788-8164-3 | Nifedipine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 4 |
| 68788-8164-6 | Nifedipine | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 4 |
| 68788-8164-9 | Nifedipine | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8164 | NIFEDIPINE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240724_cda16a27-f029-40a6-a0e8-2bed0de71169.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 |
|---|
| 68788-8164-1 | 68788816401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8164-1) | 2022-04-04 | 0000-00-00 | No | No | Current |
| 68788-8164-3 | 68788816403 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8164-3) | 2022-04-04 | 0000-00-00 | No | No | Current |
| 68788-8164-6 | 68788816406 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8164-6) | 2022-04-04 | 0000-00-00 | No | No | Current |
| 68788-8164-9 | 68788816409 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8164-9) | 2022-04-04 | 0000-00-00 | No | No | Current |