Prescription drug · ANDA
Nifedipine NDC 55154-4157
Nifedipine 60 mg/1 · Tablet, Film coated, Extended release · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-4157-0 | 55154415700 | 10 BLISTER PACK in 1 BAG (55154-4157-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 12, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210614
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 55154-4157_96097c99-cc34-4b7b-a726-bcec3850c1b5SPL ID 96097c99-cc34-4b7b-a726-bcec3850c1b5SPL set ID c98ecf77-ae9a-438b-9bad-ffbed25d95bcRxCUI 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
N455154415700followed by a unit qualifier and the quantityPackage 55154-4157-00. 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 com…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210614
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, Film coated, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-261 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-260 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-262 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Coupler LLC | 67046-0260 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8164 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2132 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6450 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-593 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1550 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7081 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-859 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-862 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7082 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-7642 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8549 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3520 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6203 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6201 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-2679 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-386 |
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