Prescription drug · ANDA
Fenoprofen Calcium NDC 85437-502
Fenoprofen calcium 300 mg/1 · Capsule · Oral · Coral Way Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85437-502-10 | 85437050210 | 100 CAPSULE in 1 BOTTLE (85437-502-10)Marketed from Jul 15, 2026 |
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)
- Fenoprofen Calcium
- Generic name (nonproprietary)
- fenoprofen calcium
- Active ingredients
- Fenoprofen calcium — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Coral Way Pharma, LLC
- 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 85437-502_56b075a0-c313-b6cb-e063-6394a90a72fdSPL ID 56b075a0-c313-b6cb-e063-6394a90a72fdSPL set ID 56b07659-1fd8-4c3e-e063-6294a90a8908RxCUI 197695UNII 0X2CW1QABJUPC 0385437502106
- 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
N485437050210followed by a unit qualifier and the quantityPackage 85437-0502-10. 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 arthrites. 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 300 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0502 |
| Fenoprofen Calcium | Fenoprofen calcium 400 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0503 |