Prescription drug · ANDA
Nifedipine NDC 68382-686
Nifedipine 60 mg/1 · Tablet, Extended release · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-686-01 | 68382068601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-686-01)Marketed from Feb 2, 2018 | |
| 68382-686-10 | 68382068610 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-686-10)Marketed from Feb 2, 2018 | |
| 68382-686-95 | 68382068695 | 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-686-95)Marketed from Feb 2, 2018 |
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, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210012
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 68382-686_c0025ef1-99d7-4b31-9d99-4be010b2b9fbSPL ID c0025ef1-99d7-4b31-9d99-4be010b2b9fbSPL set ID 657221d5-9eb8-42f9-8cdc-39cefc386f51RxCUI 1812011, 1812013, 1812015UNII I9ZF7L6G2LUPC 0368382687012, 0368382686015, 0368382685018
- 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
N468382068601followed by a unit qualifier and the quantityPackage 68382-0686-01. 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 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 210012
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 | Zydus Pharmaceuticals (USA) Inc. | 68382-685 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-687 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1190 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1191 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1192 |