Prescription drug · ANDA
Ibuprofen NDC 65162-464
Ibuprofen 400 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-464-03 | 65162046403 | 30 TABLET in 1 BOTTLE (65162-464-03)Marketed from Nov 23, 2009 | |
| 65162-464-06 | 65162046406 | 60 TABLET in 1 BOTTLE (65162-464-06)Marketed from Nov 23, 2009 | |
| 65162-464-09 | 65162046409 | 90 TABLET in 1 BOTTLE (65162-464-09)Marketed from Nov 23, 2009 | |
| 65162-464-10 | 65162046410 | 100 TABLET in 1 BOTTLE (65162-464-10)Marketed from Nov 23, 2009 | |
| 65162-464-50 | 65162046450 | 500 TABLET in 1 BOTTLE (65162-464-50)Marketed from Nov 23, 2009 |
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 — 400 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078558
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-464_0f7ab00a-cc41-400d-abfd-0febb84ed8bbSPL ID 0f7ab00a-cc41-400d-abfd-0febb84ed8bbSPL set ID 17577b3b-e755-45d1-8b53-775d058578b2RxCUI 197805, 197806, 197807UNII WK2XYI10QMUPC 0365162464030, 0365162465037, 0365162466034
- 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
N465162046403followed by a unit qualifier and the quantityPackage 65162-0464-03. 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 Tablets. 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 078558
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 400 mg/1 | TabletOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-464 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | PHOENIX RX LLC | 85509-1466 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3415 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1470 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-898 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0047 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Proficient Rx LP | 63187-022 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Proficient Rx LP | 63187-489 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-465 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-464 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-466 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Proficient Rx LP | 63187-527 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-6616 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2583 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | American Health Packaging | 60687-446 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-466 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-465 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | American Health Packaging | 60687-457 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Proficient Rx LP | 63187-962 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | American Health Packaging | 60687-468 |