Nifedipine
- Product NDC
- 62135-522
- 11-digit product format
- 621350522
- Labeler code
- 62135
- Product ID
- 62135-522_462a6c34-db5b-8d31-e063-6294a90ae196
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nifedipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA077127
- Marketing category
- ANDA
- Marketing start
- 2005-11-21
- 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 |
|---|
| 62135-522-90 | Nifedipine | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-522 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [CHARTWELL RX, LLC] | 2 | Current NDC, 1 package rows | 20241025_0a8e3090-7733-4914-bacb-01bbdc8deb30.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-522-90 | 62135052290 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-522-90) | 2023-04-11 | No | No | Current |