Prescription drug · ANDA
Oxaprozin NDC 55111-170
Oxaprozin 600 mg/1 · Tablet, Film coated · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-170-01 | 5511101700155111017001 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-170-01)Marketed from Jan 31, 2001 | |
| 55111-170-05 | 5511101700555111017005 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-170-05)Marketed from Jan 31, 2001 |
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)
- Oxaprozin
- Generic name (nonproprietary)
- oxaprozin
- Active ingredients
- Oxaprozin — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- 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 55111-170_4aa1c6b5-21ff-e110-63cf-a5c0f1b66493SPL ID 4aa1c6b5-21ff-e110-63cf-a5c0f1b66493SPL set ID da457b34-ca08-60df-045b-1ae80d2f7e71RxCUI 312132UNII MHJ80W9LRBUPC 0355111170013
- 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
N455111017001followed by a unit qualifier and the quantityPackage 55111-0170-01. 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 55111-170
- What is NDC 55111-170?
- 55111-170 is the product NDC for Oxaprozin, Oxaprozin 600 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 2 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?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 | Bryant Ranch Prepack | 71335-0393 | 71335-0393-0171335-0393-0271335-0393-03+4 more |
| 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 | ST MARY'S MEDICAL PARK PHARMACY | 60760-382 |
| Oxaprozin | Oxaprozin 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0393 |
| 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 |