Prescription drug · ANDA
Nifedipine NDC 51407-622
Nifedipine 30 mg/1 · Tablet, Extended release · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-622-01 | 51407062201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-622-01)Marketed from Jan 5, 2022 | |
| 51407-622-03 | 51407062203 | 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-622-03)Marketed from Jan 5, 2022 |
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 — 30 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202987
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 51407-622_5465a1e5-a36a-05ee-e063-6294a90ad0fdSPL ID 5465a1e5-a36a-05ee-e063-6294a90ad0fdSPL set ID d9a501be-8523-3924-e053-2995a90a8569RxCUI 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
N451407062201followed by a unit qualifier and the quantityPackage 51407-0622-01. 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, USP 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 202987
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 90 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-624 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-623 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-841 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-620 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-621 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-622 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-780 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-689 |