Prescription drug · ANDA
Oxaprozin NDC 71335-0393
Oxaprozin 600 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0393-1 | 7133503930171335039301 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0393-1)Marketed from Sep 12, 2007 | |
| 71335-0393-2 | 7133503930271335039302 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-0393-2)Marketed from Sep 12, 2007 | |
| 71335-0393-3 | 7133503930371335039303 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-0393-3)Marketed from Sep 12, 2007 | |
| 71335-0393-4 | 7133503930471335039304 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0393-4)Marketed from Sep 12, 2007 | |
| 71335-0393-5 | 7133503930571335039305 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0393-5)Marketed from Sep 12, 2007 | |
| 71335-0393-6 | 7133503930671335039306 | 6 TABLET, FILM COATED in 1 BOTTLE (71335-0393-6)Marketed from Sep 12, 2007 | |
| 71335-0393-7 | 7133503930771335039307 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0393-7)Marketed from Sep 12, 2007 |
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, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075855
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-0393_115ad76f-3895-41b7-bc5a-a7a0975aca9dSPL ID 115ad76f-3895-41b7-bc5a-a7a0975aca9dSPL set ID dcb85e40-3427-4e56-910d-c1b07bb5c0faRxCUI 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
N471335039301followed by a unit qualifier and the quantityPackage 71335-0393-01. 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.
About NDC 71335-0393
- What is NDC 71335-0393?
- 71335-0393 is the product NDC for Oxaprozin, Oxaprozin 600 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxaprozin.
- What is the active ingredient?
- Oxaprozin.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxaprozin?
- 8 other product NDCs are listed under this name. See all Oxaprozin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxaprozin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxaprozin | Oxaprozin 300 mg/1 | CapsuleOral | SOLA Pharmaceuticals, LLC | 70512-787 | 70512-0787-60 |
| Oxaprozin | Oxaprozin 600 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-595 | 72189-0595-60 |
| Oxaprozin | Oxaprozin 600 mg/1 | Tablet, Film coatedOral | ST MARY'S MEDICAL PARK PHARMACY | 60760-382 | 60760-0382-14 |
| Oxaprozin | Oxaprozin 600 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1120 | 69238-1120-0169238-1120-05 |
| Oxaprozin | Oxaprozin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0617 | 71335-0617-0171335-0617-0271335-0617-03+4 more |
| Oxaprozin | Oxaprozin 600 mg/1 | TabletOral | Chartwell RX, LLC. | 62135-176 | 62135-0176-1862135-0176-60 |
| Oxaprozin | Oxaprozin 600 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-170 | 55111-0170-0155111-0170-05 |
| Oxaprozin | Oxaprozin 600 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-261 | 82804-0261-60 |
Other NDCs under ANDA 075855
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 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-170 |
| Oxaprozin | Oxaprozin 600 mg/1 | Tablet, Film coatedOral | ST MARY'S MEDICAL PARK PHARMACY | 60760-382 |
| Oxaprozin | Oxaprozin 600 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-595 |
| Oxaprozin | Oxaprozin 600 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-261 |