Prescription drug · ANDA
Nifedipine NDC 71205-412
Nifedipine 60 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-412-30 | 7120504123071205041230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-412-30)Marketed from Feb 26, 2020 | |
| 71205-412-60 | 7120504126071205041260 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-412-60)Marketed from Feb 26, 2020 | |
| 71205-412-90 | 7120504129071205041290 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-412-90)Marketed from Feb 26, 2020 |
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
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203126
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 71205-412_838d6e8f-37b0-48d3-b701-c4fa32a87b85SPL ID 838d6e8f-37b0-48d3-b701-c4fa32a87b85SPL set ID 838d6e8f-37b0-48d3-b701-c4fa32a87b85RxCUI 1812013UNII 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
N471205041230followed by a unit qualifier and the quantityPackage 71205-0412-30. 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.
About NDC 71205-412
- What is NDC 71205-412?
- 71205-412 is the product NDC for Nifedipine, Nifedipine 60 mg/1 tablet, extended release, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, 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?
- Proficient Rx LP, NDC labeler code 71205. 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 Limited | 46708-732 | 46708-0732-3146708-0732-6346708-0732-91 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-733 | 46708-0733-3146708-0733-63 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-734 | 46708-0734-31 |
Other NDCs under ANDA 203126
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 | Upsher-Smith Laboratories, LLC | 24979-010 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-009 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-009 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-010 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-011 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-011 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-738 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4097 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-9651 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-290 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-990 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-1277 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 60429-047 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 60429-048 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 60429-049 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7208 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-963 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-964 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-965 |