Prescription drug · ANDA
Nifedipine NDC 62332-734
Nifedipine 90 mg/1 · Tablet, Extended release · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-734-31 | 62332073431 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-734-31)Marketed from Nov 23, 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 — 90 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216896
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 62332-734_69114afa-390f-4134-9055-d0b539d45c96SPL ID 69114afa-390f-4134-9055-d0b539d45c96SPL set ID 63f062f6-5669-434c-8ded-9801d8486dbfRxCUI 1812011, 1812013, 1812015UNII I9ZF7L6G2LUPC 0362332734313, 0362332732319, 0362332733316
- 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
N462332073431followed by a unit qualifier and the quantityPackage 62332-0734-31. 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.
About NDC 62332-734
- What is NDC 62332-734?
- 62332-734 is the product NDC for Nifedipine, Nifedipine 90 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nifedipine.
- What is the active ingredient?
- Nifedipine.
- Who is the labeler?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nifedipine?
- 127 other product NDCs are listed under this name. See all Nifedipine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nifedipine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Coupler LLC | 67046-0260 | 67046-0260-03 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4625 | 70518-4625-00 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0196 | 55154-0196-00 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-862 | 60760-0862-90 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-859 | 60760-0859-90 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-386 | 51655-0386-52 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-593 | 51655-0593-26 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-732 | 62332-0732-3162332-0732-6362332-0732-91 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-733 | 62332-0733-3162332-0733-63 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-732 | 46708-0732-3146708-0732-6346708-0732-91 |
Other NDCs under ANDA 216896
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 60 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-733 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-732 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-732 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-733 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-734 |