Prescription drug · ANDA
Nifedipine NDC 63629-9109
Nifedipine 30 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-9109-1 | 63629910901 | 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-9109-1)Marketed from Feb 16, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 30 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075269
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 63629-9109_f322be76-93f3-42e0-9435-9ce0605cd2aeSPL ID f322be76-93f3-42e0-9435-9ce0605cd2aeSPL set ID 59724871-b495-4911-a86d-20069ec42eddRxCUI 198034UNII 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
N463629910901followed by a unit qualifier and the quantityPackage 63629-9109-01. 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)
INDICATIONS 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 075269
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 60 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-012 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2260 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-144 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-1887 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-105 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Oceanside Pharmaceuticals | 68682-106 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-798 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5284 |