Prescription drug · ANDA
Fenoprofen Calcium NDC 0276-0502
Fenoprofen calcium 300 mg/1 · Capsule · Oral · Misemer Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0276-0502-10 | 00276050210 | 100 CAPSULE in 1 BOTTLE (0276-0502-10)Marketed from Nov 1, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Fenoprofen Calcium
- Generic name (nonproprietary)
- fenoprofen calcium
- Active ingredients
- Fenoprofen calcium — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215548
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 0276-0502_597fecff-90ac-274c-e063-6294a90a1609SPL ID 597fecff-90ac-274c-e063-6294a90a1609SPL set ID d33ad329-1ca6-ac2e-e053-2995a90a15c5RxCUI 197694, 197695, 858116UNII 0X2CW1QABJ
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N400276050210followed by a unit qualifier and the quantityPackage 00276-0502-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
1. INDICATIONS AND USAGE FENOPROFEN CALCIUM is indicated for: • Relief of mild to moderate pain in adults • Relief of the signs and symptoms of rheumatoid arthritis • Relief of the signs and symptoms of osteoarthritis FENOPROFEN CALCIUM is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults. ( 1 ) Relief of the signs and symptoms of rheumatoid arthritis. ( 1 ) Relief of the signs and symptoms of osteoarthritis. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215548
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 |
|---|---|---|---|---|
| Fenoprofen Calcium | Fenoprofen calcium 200 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0501 |
| Fenoprofen Calcium | Fenoprofen calcium 400 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0503 |
| Fenoprofen Calcium | Fenoprofen calcium 300 mg/1 | CapsuleOral | Coral Way Pharma, LLC | 85437-502 |