Prescription drug · ANDA
Fenoprofen Calcium NDC 16571-886
Fenoprofen calcium 200 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-886-01 | 16571088601 | 100 CAPSULE in 1 BOTTLE (16571-886-01)Marketed from Jul 26, 2024 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214475
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 16571-886_ba5e0066-40c5-4ea4-bd0c-cfcb18bdbc48SPL ID ba5e0066-40c5-4ea4-bd0c-cfcb18bdbc48SPL set ID 4aa38cca-9f8f-4ab6-8103-4f1f48801a43RxCUI 197694, 197695, 858116UNII 0X2CW1QABJUPC 0316571688098
- 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
N416571088601followed by a unit qualifier and the quantityPackage 16571-0886-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
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 214475
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 300 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-887 |
| Fenoprofen Calcium | Fenoprofen calcium 400 mg/1 | CapsuleOral | Proficient Rx LP | 71205-828 |
| Fenoprofen Calcium | Fenoprofen calcium 400 mg/1 | CapsuleOral | Atland Pharmaceuticals, LLC | 71993-308 |
| Fenoprofen calcium | Fenoprofen calcium 200 mg/1 | CapsuleOral | Atland Pharmaceuticals, LLC | 71993-313 |
| Fenopron Tmfenoprofen calcium | Fenoprofen calcium 300 mg/1 | CapsuleOral | Galt Pharmaceuticals, LLC | 61825-311 |
| Fenoprofen Calcium | Fenoprofen calcium 400 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-688 |