Prescription drug · ANDA
Ibuprofen NDC 42708-175
Ibuprofen 600 mg/1 · Tablet, Film coated · Oral · QPharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42708-175-30 | 42708017530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-175-30)Marketed from Jun 20, 2023 · Sample package |
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)
- Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- QPharma Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091625
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 42708-175_519ebcae-72ae-7a7a-e063-6294a90ad268SPL ID 519ebcae-72ae-7a7a-e063-6294a90ad268SPL set ID fd8b82a7-96fe-8bf5-e053-6394a90a3935RxCUI 197806UNII WK2XYI10QM
- 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
N442708017530followed by a unit qualifier and the quantityPackage 42708-0175-30. 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 ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091625
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 |
|---|---|---|---|---|
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0761 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-980 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-321 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-319 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-320 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-992 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Granules India Limited | 62207-356 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Granules India Limited | 62207-354 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Granules India Limited | 62207-355 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-068 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-066 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-067 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-042 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-048 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3178 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-044 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Legacy Pharmaceutical Packaging, LLC | 68645-562 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Legacy Pharmaceutical Packaging, LLC | 68645-563 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1051 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1073 |
Showing 20 of 39.