Prescription drug · ANDA
Nifedipine NDC 59651-296
Nifedipine 60 mg/1 · Tablet, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-296-01 | 59651029601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-296-01)Marketed from Jul 19, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nifedipine
- Generic name (nonproprietary)
- nifedipine
- Active ingredients
- Nifedipine — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213361
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 59651-296_4d72a04e-43a6-4fa4-bd1c-1360c4539d71SPL ID 4d72a04e-43a6-4fa4-bd1c-1360c4539d71SPL set ID eb70b7ff-f9f0-41d0-901a-f4c04ae9ed46RxCUI 198034, 198035, 198036UNII I9ZF7L6G2L
- Pharmacologic class
- Dihydropyridine Calcium Channel Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459651029601followed by a unit qualifier and the quantityPackage 59651-0296-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATION AND USAGE Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213361
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Redpharm Drug | 67296-2170 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2535 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2534 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2536 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2838 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 59651-297 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 59651-295 |