Prescription drug · ANDA
Ibuprofen NDC 0904-5853
Ibuprofen 400 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-5853-40 | 00904585340 | 500 TABLET in 1 BOTTLE (0904-5853-40)Marketed from Jun 10, 2009 | |
| 0904-5853-60 | 00904585360 | 100 TABLET in 1 BOTTLE (0904-5853-60)Marketed from Jun 10, 2009 | |
| 0904-5853-61 | 00904585361 | 100 BLISTER PACK in 1 CARTON (0904-5853-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 10, 2009 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075682
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-5853_4328fb1d-573c-4d05-8019-1d2c29360cc5SPL ID 4328fb1d-573c-4d05-8019-1d2c29360cc5SPL set ID ba86e936-ef72-43e5-aebf-f2c788fe2266RxCUI 197805, 197806, 197807UNII 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
N400904585340followed by a unit qualifier and the quantityPackage 00904-5853-40. 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 Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual 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 075682
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 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-967 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-968 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-969 |
| Ibuibuprofen | Ibuprofen 400 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-682 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-683 |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-684 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Proficient Rx LP | 63187-614 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5854 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5855 |
| Ibuibuprofen | Ibuprofen 400 mg/1 | TabletOral | Proficient Rx LP | 71205-604 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-501 |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-963 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | NuCare Pharmaceuticals Inc. | 66267-964 |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3053 |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-550 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-547 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1468 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-891 |
| Ibuibuprofen | Ibuprofen 400 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-369 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-892 |
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