Prescription drug · ANDA
Ibu (ibuprofen) NDC 63187-614
Ibuprofen 600 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-614-15 | 63187061415 | 15 TABLET in 1 BOTTLE (63187-614-15)Marketed from Jan 1, 2016 | |
| 63187-614-20 | 63187061420 | 20 TABLET in 1 BOTTLE (63187-614-20)Marketed from Mar 1, 2017 | |
| 63187-614-21 | 63187061421 | 21 TABLET in 1 BOTTLE (63187-614-21)Marketed from Dec 11, 2025 | |
| 63187-614-28 | 63187061428 | 28 TABLET in 1 BOTTLE (63187-614-28)Marketed from Oct 1, 2019 | |
| 63187-614-30 | 63187061430 | 30 TABLET in 1 BOTTLE (63187-614-30)Marketed from Jan 1, 2016 | |
| 63187-614-40 | 63187061440 | 40 TABLET in 1 BOTTLE (63187-614-40)Marketed from Jun 1, 2017 | |
| 63187-614-42 | 63187061442 | 42 TABLET in 1 BOTTLE (63187-614-42)Marketed from Feb 21, 2020 | |
| 63187-614-45 | 63187061445 | 45 TABLET in 1 BOTTLE (63187-614-45)Marketed from Jan 1, 2016 | |
| 63187-614-60 | 63187061460 | 60 TABLET in 1 BOTTLE (63187-614-60)Marketed from Jan 1, 2016 | |
| 63187-614-90 | 63187061490 | 90 TABLET in 1 BOTTLE (63187-614-90)Marketed from Jan 1, 2016 |
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)
- Ibu
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 63187-614_144ceffa-24aa-4423-ba09-1a6fa5c0d5cfSPL ID 144ceffa-24aa-4423-ba09-1a6fa5c0d5cfSPL set ID a7098fa1-b5ae-485e-ada9-64154f81fb6aRxCUI 197806, 206913UNII WK2XYI10QMUPC 0363187614300
- 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
N463187061415followed by a unit qualifier and the quantityPackage 63187-0614-15. 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 ). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU 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 400 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5853 |
| 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 |
| 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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