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NDC 42195-0471-01 Fenoprofen Calcium 600 mg/1 Details
Fenoprofen Calcium 600 mg/1
Fenoprofen Calcium is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Xspire Pharma, Llc. The primary component is FENOPROFEN CALCIUM.
MedlinePlus Drug Summary
Fenoprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Fenoprofen is also used to relieve mild to moderate pain from other causes. Fenoprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 42195-0471-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fenoprofen
Product Information
| NDC | 42195-0471 |
|---|---|
| Product ID | 42195-471_079e140a-b3a2-1c2e-e063-6394a90a8491 |
| Associated GPIs | 66100010100305 |
| GCN Sequence Number | 008353 |
| GCN Sequence Number Description | fenoprofen calcium TABLET 600 MG ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 35760 |
| HICL Sequence Number | 003724 |
| HICL Sequence Number Description | FENOPROFEN CALCIUM |
| Brand/Generic | Generic |
| Proprietary Name | Fenoprofen Calcium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fenoprofen Calcium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 600 |
| Active Ingredient Units | mg/1 |
| Substance Name | FENOPROFEN CALCIUM |
| Labeler Name | Xspire Pharma, Llc |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA072267 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42195-0471-01 (42195047101)
| NDC Package Code | 42195-471-01 |
|---|---|
| Billing NDC | 42195047101 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (42195-471-01) |
| Marketing Start Date | 2018-02-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |