nifedipine
- Product NDC
- 70807-503
- 11-digit product format
- 708070503
- Labeler code
- 70807
- Product ID
- 70807-503_3816123b-e06c-4abf-aead-2bed62b89c15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nifedipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Elite Pharmaceutical Solution, Inc.
- Application
- ANDA212016
- Marketing category
- ANDA
- Marketing start
- 2021-10-15
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70807-503-12 | nifedipine | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 3 |
| 70807-503-13 | nifedipine | 300 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 300 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70807-503 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [ELITE PHARMACEUTICAL SOLUTION, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240111_1df07edb-630d-4c70-a68c-bdbc607ce850.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 |
|---|
| 70807-503-12 | 70807050312 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70807-503-12) | 2021-10-15 | 0000-00-00 | No | No | Current |
| 70807-503-13 | 70807050313 | 300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70807-503-13) | 2021-10-15 | 0000-00-00 | No | No | Current |