Prescription drug · ANDA
Ketoprofen NDC 85477-111
Ketoprofen 50 mg/1 · Capsule · Oral · Oncora Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85477-111-01 | 85477011101 | 100 CAPSULE in 1 BOTTLE (85477-111-01)Marketed from Mar 1, 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)
- Ketoprofen
- Generic name (nonproprietary)
- ketoprofen
- Active ingredients
- Ketoprofen — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Oncora Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074014
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 85477-111_0b2637a6-551b-4be3-8d1a-dad8fbf764b0SPL ID 0b2637a6-551b-4be3-8d1a-dad8fbf764b0SPL set ID 492de5dc-7c1b-47be-8510-43be4e1fd4edRxCUI 197855UNII 90Y4QC304K
- 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
N485477011101followed by a unit qualifier and the quantityPackage 85477-0111-01. 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)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketoprofen capsules USP and other treatment options before deciding to use ketoprofen capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Ketoprofen capsules USP are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen capsules USP are indicated for the management of pain. Ketoprofen capsules USP are also indicated for treatment of primary dysmenorrhea.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074014
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 |
|---|---|---|---|---|
| Ketoprofen | Ketoprofen 50 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0506 |
| Ketoprofen | Ketoprofen 75 mg/1 | CapsuleOral | Marnel Pharmaceuticals, Inc. | 0682-0150 |
| Ketoprofen | Ketoprofen 75 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0507 |
| Ketoprofen | Ketoprofen 25 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0504 |
| Orudisketoprofen | Ketoprofen 75 mg/1 | CapsuleOral | Allegis Pharmaceuticals, Inc. | 28595-031 |