Prescription drug · ANDA
Nifedipine NDC 67877-756
Nifedipine 90 mg/1 · Tablet, Extended release · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-756-01 | 6787707560167877075601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-756-01)Marketed from Mar 30, 2022 | |
| 67877-756-05 | 6787707560567877075605 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-756-05)Marketed from Mar 30, 2022 | |
| 67877-756-58 | 6787707565867877075658 | 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-756-58)Marketed from Dec 30, 2022 | |
| 67877-756-90 | 6787707569067877075690 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-756-90)Marketed from Mar 30, 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
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216067
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 67877-756_2833cb85-4017-41e2-aa4a-c19371ba85e8SPL ID 2833cb85-4017-41e2-aa4a-c19371ba85e8SPL set ID f661c1d9-f0f6-4595-82dd-f656bff974f1RxCUI 1812011, 1812013, 1812015UNII I9ZF7L6G2LUPC 0367877758589
- 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
N467877075601followed by a unit qualifier and the quantityPackage 67877-0756-01. 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 & 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 67877-756
- What is NDC 67877-756?
- 67877-756 is the product NDC for Nifedipine, Nifedipine 90 mg/1 tablet, extended release, listed with the FDA by Ascend Laboratories, LLC. It has 4 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 216067
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 | A-S Medication Solutions | 50090-6732 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6767 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-757 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-758 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-484 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-485 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-486 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Redpharm Drug | 67296-2157 |