Prescription drug · ANDA
Ibuprofen NDC 69238-1103
Ibuprofen 800 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1103-5 | 69238110305 | 500 TABLET, FILM COATED in 1 BOTTLE (69238-1103-5)Marketed from Apr 1, 2014 |
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)
- Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 800 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078329
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69238-1103_9fdca868-ff3e-4871-9921-9ef7adc577e5SPL ID 9fdca868-ff3e-4871-9921-9ef7adc577e5SPL set ID e07d989d-1b0e-4cc1-abf2-93c8b208a29aRxCUI 197805, 197806, 197807UNII WK2XYI10QMUPC 0369238110159, 0369238110357, 0369238110258
- 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
N469238110305followed by a unit qualifier and the quantityPackage 69238-1103-05. 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 078329
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 | Direct_Rx | 72189-643 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3108 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4741 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5228 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0537 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-808 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-807 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-809 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-629 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-890 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-895 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-464 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | SOLA Pharmaceuticals, LLC | 70512-780 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-415 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4845 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8531 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4887 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1206 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8309 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1207 |
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