Prescription drug · ANDA
Nifedipine ER (Nifedipine) NDC 50268-598
Nifedipine 60 mg/1 · Tablet, Film coated, Extended release · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-598-15 | 50268059815 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-598-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-598-11)Marketed from Feb 11, 2011 |
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 ERSuffix: ER
- Generic name (nonproprietary)
- nifedipine
- Active ingredients
- Nifedipine — 60 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- AvPAKNDC labeler code 50268
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077127
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 50268-598_47e7d21f-e346-6413-e063-6294a90aa9beSPL ID 47e7d21f-e346-6413-e063-6294a90aa9beSPL set ID d1a78ff2-7672-3e69-00ef-63d203c80484RxCUI 1812011, 1812013, 1812015UNII 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
N450268059815followed by a unit qualifier and the quantityPackage 50268-0598-15. 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 Tablet is 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 Tablet may also be used where the clinical presentation suggests a possible vasospastic compo…
Excerpt only. Read the full label for complete information.
About NDC 50268-598
- What is NDC 50268-598?
- 50268-598 is the product NDC for Nifedipine ER (nifedipine), Nifedipine 60 mg/1 tablet, film coated, extended release, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nifedipine ER (Nifedipine).
- What is the active ingredient?
- Nifedipine.
- Who is the labeler?
- AvPAK, NDC labeler code 50268. 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 ER?
- 2 other product NDCs are listed under this name. See all Nifedipine ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nifedipine ER 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 ERnifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | AvPAK | 50268-597 | 50268-0597-15 |
| Nifedipine ERnifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | AvPAK | 50268-599 | 50268-0599-15 |
Other NDCs under ANDA 077127
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 | American Health Packaging | 68084-598 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 68084-603 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 107, LLC | 55154-4690 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 55289-798 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 63187-875 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | Lannett Company, Inc. | 62175-262 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Lannett Company, Inc. | 62175-260 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | Lannett Company, Inc. | 62175-261 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | A-S Medication Solutions | 50090-4158 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-494 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Chartwell RX, LLC | 62135-521 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 107, LLC | 55154-8177 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | Chartwell RX, LLC | 62135-522 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | Chartwell RX, LLC | 62135-523 |
| Nifedipine ERnifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | AvPAK | 50268-597 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | American Health Packaging | 68084-597 |