Nifedipine
- Product NDC
- 68084-597
- 11-digit product format
- 680840597
- Labeler code
- 68084
- Product ID
- 68084-597_35460830-1534-dc42-e063-6394a90a1e57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nifedipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077127
- Marketing category
- ANDA
- Marketing start
- 2012-06-13
- Substance
- NIFEDIPINE
- Active strength
- 30 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 | 30 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 |
|---|
| 68084-597-01 | Nifedipine | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED, EXTENDED RE | 100 | | 10 |
| 68084-597-11 | Nifedipine | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 10 |
| 68084-597-65 | Nifedipine | 50 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 50 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-597 | NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 10 | Current NDC, Legacy NDC, 3 package rows | 20250522_b11026f8-dea0-49ac-8725-0ef7dc27923f.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 |
|---|
| 68084-597-01 | 68084059701 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-597-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-597-11) | 100 blister pack | 2012-06-13 | 0000-00-00 | No | No | Current |
| 68084-597-11 | 68084059711 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68084-597-65 | 68084059765 | 50 BLISTER PACK in 1 CARTON (68084-597-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-597-11) | 50 blister pack | 2023-02-06 | | No | No | Current |