Nifedipine
- Product NDC
- 50742-260
- 11-digit product format
- 507420260
- Labeler code
- 50742
- Product ID
- 50742-260_2d798366-5fb6-4ea5-b1cc-663a0c3290b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nifedipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA210614
- Marketing category
- ANDA
- Marketing start
- 2019-03-12
- 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
- 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 |
|---|---|
| NIFEDIPINE | 30 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | I9ZF7L6G2L |
| Rxcui | 1812011, 1812013, 1812015 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bbd94e90-e531-9113-45c1-29860f331640 | Product name | 7 | 20230104 |
| 5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffd | Product name | 4 | 20220126 |
| 308fd2ea-d88a-e021-96c1-7c2ab74d6e4b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50742-260-01 | Nifedipine | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 6 | |
| 50742-260-03 | Nifedipine | 300 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 300 | 6 | |
| 50742-260-30 | Nifedipine | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1812011 | NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet | PSN | 24e56333-5601-48fd-a263-f6be90983fb4 | 10 |
| 1812011 | Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet | SCD | 24e56333-5601-48fd-a263-f6be90983fb4 | 10 |
| 1812011 | nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet | SY | 24e56333-5601-48fd-a263-f6be90983fb4 | 10 |
| 1812011 | NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet | PSN | 4ee466dc-5a4e-4c77-8e94-8b510cafd61b | 6 |
| 1812011 | NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet | PSN | 4d3e11d2-d320-45d3-96c8-48322202b504 | 6 |
| 1812013 | NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet | PSN | 4d3e11d2-d320-45d3-96c8-48322202b504 | 6 |
| 1812015 | NIFEdipine 90 MG Osmotic 24HR Extended Release Oral Tablet | PSN | 4d3e11d2-d320-45d3-96c8-48322202b504 | 6 |
| 1812011 | Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet | SCD | 4d3e11d2-d320-45d3-96c8-48322202b504 | 6 |
| 1812011 | Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet | SCD | 4ee466dc-5a4e-4c77-8e94-8b510cafd61b | 6 |
| 1812013 | Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet | SCD | 4d3e11d2-d320-45d3-96c8-48322202b504 | 6 |
| 1812015 | Osmotic 24 HR nifedipine 90 MG Extended Release Oral Tablet | SCD | 4d3e11d2-d320-45d3-96c8-48322202b504 | 6 |
| 1812011 | nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet | SY | 4d3e11d2-d320-45d3-96c8-48322202b504 | 6 |
| 1812011 | nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet | SY | 4ee466dc-5a4e-4c77-8e94-8b510cafd61b | 6 |
| 1812013 | nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet | SY | 4d3e11d2-d320-45d3-96c8-48322202b504 | 6 |
| 1812015 | nifedipine 90 MG Osmotic 24 HR Extended Release Oral Tablet | SY | 4d3e11d2-d320-45d3-96c8-48322202b504 | 6 |
| 1812011 | NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet | PSN | 3334ab6f-aeb0-4b78-8d17-f0aedd94f996 | 5 |
| 1812011 | NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet | PSN | 325acf27-4b2e-40e8-8344-bb6cc9959910 | 5 |
| 1812011 | Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet | SCD | 325acf27-4b2e-40e8-8344-bb6cc9959910 | 5 |
| 1812011 | Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet | SCD | 3334ab6f-aeb0-4b78-8d17-f0aedd94f996 | 5 |
| 1812011 | nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet | SY | 325acf27-4b2e-40e8-8344-bb6cc9959910 | 5 |
| 1812011 | nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet | SY | 3334ab6f-aeb0-4b78-8d17-f0aedd94f996 | 5 |
| 1812011 | NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet | PSN | f32c0fc9-b4ad-6a1f-e053-2995a90acf61 | 3 |
| 1812011 | Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet | SCD | f32c0fc9-b4ad-6a1f-e053-2995a90acf61 | 3 |
| 1812011 | nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet | SY | f32c0fc9-b4ad-6a1f-e053-2995a90acf61 | 3 |
| 1812011 | NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet | PSN | d5df10bc-16ed-7a97-e053-2a95a90ab15e | 2 |
| 1812011 | Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet | SCD | d5df10bc-16ed-7a97-e053-2a95a90ab15e | 2 |
| 1812011 | nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet | SY | d5df10bc-16ed-7a97-e053-2a95a90ab15e | 2 |
| 1812011 | NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet | PSN | 518d39af-0be1-acbc-e063-6294a90a4ada | 1 |
| 1812011 | Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet | SCD | 518d39af-0be1-acbc-e063-6294a90a4ada | 1 |
| 1812011 | nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet | SY | 518d39af-0be1-acbc-e063-6294a90a4ada | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50742-260-01 | 50742026001 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-260-01) | 2019-03-12 | 0000-00-00 | No | No | Current |
| 50742-260-03 | 50742026003 | 300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-260-03) | 2019-03-12 | 0000-00-00 | No | No | Current |
| 50742-260-30 | 50742026030 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-260-30) | 2019-03-12 | 0000-00-00 | No | No | Current |