Prescription drug · ANDA
Ibuprofen NDC 63629-1468
Ibuprofen 400 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1468-1 | 63629146801 | 20 TABLET in 1 BOTTLE (63629-1468-1)Marketed from Oct 27, 2011 | |
| 63629-1468-2 | 63629146802 | 30 TABLET in 1 BOTTLE (63629-1468-2)Marketed from Oct 29, 2024 | |
| 63629-1468-3 | 63629146803 | 40 TABLET in 1 BOTTLE (63629-1468-3)Marketed from Oct 29, 2024 | |
| 63629-1468-4 | 63629146804 | 60 TABLET in 1 BOTTLE (63629-1468-4)Marketed from Oct 29, 2024 | |
| 63629-1468-5 | 63629146805 | 90 TABLET in 1 BOTTLE (63629-1468-5)Marketed from Apr 29, 2011 | |
| 63629-1468-6 | 63629146806 | 120 TABLET in 1 BOTTLE (63629-1468-6)Marketed from Sep 26, 2012 | |
| 63629-1468-7 | 63629146807 | 100 TABLET in 1 BOTTLE (63629-1468-7)Marketed from Jan 21, 2011 | |
| 63629-1468-8 | 63629146808 | 21 TABLET in 1 BOTTLE (63629-1468-8)Marketed from Jan 10, 2012 | |
| 63629-1468-9 | 63629146809 | 15 TABLET in 1 BOTTLE (63629-1468-9)Marketed from Dec 4, 2013 |
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 — 400 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 63629-1468_ffbc9f9d-60df-4552-80fa-e29c831ecc41SPL ID ffbc9f9d-60df-4552-80fa-e29c831ecc41SPL set ID 7650f84b-92f2-4065-8ef2-f5de5bd7002bRxCUI 197805UNII 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
N463629146801followed by a unit qualifier and the quantityPackage 63629-1468-01. 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)
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 600 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5854 |
| Ibuibuprofen | Ibuprofen 400 mg/1 | TabletOral | Proficient Rx LP | 71205-604 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-501 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5855 |
| 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 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-891 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-892 |
| Ibuibuprofen | Ibuprofen 400 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-369 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0741 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9111 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9110 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1342 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9112 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1380 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-547 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-839 |
| Ibu | Ibuprofen 600 mg/1 | TabletOral | RedPharm Drug, Inc. | 67296-0913 |
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