NIFEdipine
- Product NDC
- 69315-211
- 11-digit product format
- 693150211
- Labeler code
- 69315
- Product ID
- 69315-211_4f9b849c-719a-492b-9889-6766a4544c54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NIFEdipine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA073250
- Marketing category
- ANDA
- Marketing start
- 2016-11-23
- Substance
- NIFEDIPINE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I9ZF7L6G2L |
| Rxcui | 198032 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-211-01 | NIFEdipine | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-211 | NIFEDIPINE CAPSULE [LEADING PHARMA, LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20241009_10b854c5-e7b3-46bd-b4d6-788ba5d601e1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69315-211-01 | 69315021101 | 100 CAPSULE in 1 BOTTLE, PLASTIC (69315-211-01) | 100 capsule | 2018-10-02 | 0000-00-00 | No | No | Current |