Prescription drug · ANDA
Nifedipine NDC 62135-739
Nifedipine 10 mg/1 · Capsule · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-739-90 | 62135073990 | 90 CAPSULE in 1 BOTTLE (62135-739-90)Marketed from Aug 8, 2023 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202644
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 62135-739_462a6e34-b07c-965d-e063-6294a90ab52bSPL ID 462a6e34-b07c-965d-e063-6294a90ab52bSPL set ID 5014847e-389d-48c1-8350-b9b24ca8d2a4RxCUI 198032, 198033UNII I9ZF7L6G2LUPC 0362135739904, 0362135740900
- 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
N462135073990followed by a unit qualifier and the quantityPackage 62135-0739-90. 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 I. Vasospastic Angina Nifedipine is 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 may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed,…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202644
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 10 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0196 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7229 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4625 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-219 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-194 |
| Nifedipine | Nifedipine 20 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-195 |
| Nifedipine | Nifedipine 20 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-740 |