Nifedipine
- Product NDC
- 51655-738
- 11-digit product format
- 516550738
- Labeler code
- 51655
- Product ID
- 51655-738_4ba99a73-55bd-5652-e063-6294a90a40e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nifedipine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA203126
- Marketing category
- ANDA
- Marketing start
- 2021-07-09
- 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
- 2027-12-31
- 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 | 90 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9ZF7L6G2L |
| Rxcui | 1812015 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-738-52 | Nifedipine | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-738 | NIFEDIPINE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 1 package rows | 20241228_da565525-c77a-0571-e053-2995a90aaa11.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-738-52 | 51655073852 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-738-52) | 2021-07-09 | No | No | Current |