Prescription drug · ANDA
Nifedipine NDC 50090-6732
Nifedipine 30 mg/1 · Tablet, Extended release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6732-0 | 50090673200 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6732-0)Marketed from Oct 6, 2023 | |
| 50090-6732-1 | 50090673201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6732-1)Marketed from Oct 6, 2023 | |
| 50090-6732-2 | 50090673202 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6732-2)Marketed from Oct 6, 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
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216067
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 50090-6732_84e4e78e-7b15-455a-934c-7a091dd95b95SPL ID 84e4e78e-7b15-455a-934c-7a091dd95b95SPL set ID 5a7951e7-f507-43e8-9bba-855b79daf170RxCUI 1812011UNII 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
N450090673200followed by a unit qualifier and the quantityPackage 50090-6732-00. 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 & USAGE I. Vasospastic Angina Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic comp…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216067
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 | Ascend Laboratories, LLC | 67877-757 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-758 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Redpharm Drug | 67296-2157 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6767 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-486 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-484 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-485 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-756 |