Prescription drug · ANDA
Fenopron Tm (Fenoprofen calcium) NDC 61825-311
Fenoprofen calcium 300 mg/1 · Capsule · Oral · Galt Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61825-311-10 | 6182503111061825031110 | 100 CAPSULE in 1 BOTTLE (61825-311-10)Marketed from Dec 10, 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)
- Fenopron TmSuffix: TM
- Generic name (nonproprietary)
- fenoprofen calcium
- Active ingredients
- Fenoprofen calcium — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Galt Pharmaceuticals, LLCNDC labeler code 61825
- 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 61825-311_1ad61a67-8758-4f2f-b7d5-f00f62ea69aaSPL ID 1ad61a67-8758-4f2f-b7d5-f00f62ea69aaSPL set ID 2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0RxCUI 197695, 2699827UNII 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
N461825031110followed by a unit qualifier and the quantityPackage 61825-0311-10. 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)
FENOPRON TM 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.
About NDC 61825-311
- What is NDC 61825-311?
- 61825-311 is the product NDC for Fenopron Tm (fenoprofen calcium), Fenoprofen calcium 300 mg/1 capsule, listed with the FDA by Galt Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fenopron Tm (Fenoprofen calcium).
- What is the active ingredient?
- Fenoprofen calcium.
- Who is the labeler?
- Galt Pharmaceuticals, LLC, NDC labeler code 61825. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fenopron Tm?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 400 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-688 |
| Fenoprofen Calcium | Fenoprofen calcium 200 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-886 |
| 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 |