Prescription drug · ANDA
Oxaprozin NDC 71335-0617
Oxaprozin 600 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0617-1 | 71335061701 | 30 TABLET in 1 BOTTLE (71335-0617-1)Marketed from Dec 27, 2021 | |
| 71335-0617-2 | 71335061702 | 20 TABLET in 1 BOTTLE (71335-0617-2)Marketed from Dec 27, 2021 | |
| 71335-0617-3 | 71335061703 | 14 TABLET in 1 BOTTLE (71335-0617-3)Marketed from Dec 27, 2021 | |
| 71335-0617-4 | 71335061704 | 60 TABLET in 1 BOTTLE (71335-0617-4)Marketed from Feb 14, 2018 | |
| 71335-0617-5 | 71335061705 | 90 TABLET in 1 BOTTLE (71335-0617-5)Marketed from Apr 5, 2018 | |
| 71335-0617-6 | 71335061706 | 6 TABLET in 1 BOTTLE (71335-0617-6)Marketed from Dec 27, 2021 | |
| 71335-0617-7 | 71335061707 | 120 TABLET in 1 BOTTLE (71335-0617-7)Marketed from Dec 27, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Oxaprozin
- Generic name (nonproprietary)
- oxaprozin
- Active ingredients
- Oxaprozin — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208633
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-0617_f128ff41-2ad3-4a5b-a34c-13d6f8940f35SPL ID f128ff41-2ad3-4a5b-a34c-13d6f8940f35SPL set ID c157016e-0777-4ad7-89b8-487c47bb74cbRxCUI 312132UNII MHJ80W9LRB
- 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
N471335061701followed by a unit qualifier and the quantityPackage 71335-0617-01. 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)
Oxaprozin tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For relief of the signs and symptoms of juvenile rheumatoid arthritis Oxaprozin is a non-steroidal anti-inflammatory drug indicated for: Relief of signs and symptoms of Osteoarthritis (OA). ( 1 ) Relief of signs and symptoms of Rheumatoid Arthritis (RA). ( 1 ) Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA). ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208633
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 |
|---|---|---|---|---|
| Oxaprozin | Oxaprozin 600 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1120 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.