Prescription drug · ANDA
nifedipine NDC 68682-109
Nifedipine 60 mg/1 · Tablet, Film coated, Extended release · Oral · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-109-10 | 68682010910 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-10)Marketed from Sep 27, 2000 | |
| 68682-109-30 | 68682010930 | 300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-30)Marketed from Sep 27, 2000 |
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, Film coated, Extended release
- Route
- Oral
- Labeler
- Oceanside Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075289
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 68682-109_68cca98c-658a-48b4-9630-478b62b1471eSPL ID 68cca98c-658a-48b4-9630-478b62b1471eSPL set ID c7874606-c71e-424c-b881-38697988e0d0RxCUI 1812011, 1812013UNII I9ZF7L6G2LUPC 0368682108101
- 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
N468682010910followed by a unit qualifier and the quantityPackage 68682-0109-10. 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 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 co…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075289
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, Film coated, Extended releaseOral | Oceanside Pharmaceuticals | 68682-108 |
| nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-0744 |