Prescription drug · ANDA
Ibuprofen NDC 71610-901
Ibuprofen 800 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-901-60 | 7161009016071610090160 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-901-60)Marketed from May 1, 2025 | |
| 71610-901-70 | 7161009017071610090170 | 120 TABLET, FILM COATED in 1 BOTTLE (71610-901-70)Marketed from May 1, 2025 | |
| 71610-901-80 | 7161009018071610090180 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-901-80)Marketed from May 1, 2025 | |
| 71610-901-92 | 7161009019271610090192 | 270 TABLET, FILM COATED in 1 BOTTLE (71610-901-92)Marketed from May 1, 2025 |
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 — 800 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202413
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-901_34675093-0bcb-d858-e063-6294a90a7198SPL ID 34675093-0bcb-d858-e063-6294a90a7198SPL set ID 34673d3b-41cd-f4c9-e063-6394a90a8510RxCUI 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
N471610090160followed by a unit qualifier and the quantityPackage 71610-0901-60. 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.
About NDC 71610-901
- What is NDC 71610-901?
- 71610-901 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen.
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibuprofen?
- 672 other product NDCs are listed under this name. See all Ibuprofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4801 | 70518-4801-00 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4784 | 70518-4784-0070518-4784-01 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4786 | 70518-4786-00 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Famora Inc | 87509-0004 | 87509-0004-05 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-724 | 82461-0724-90 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-725 | 82461-0725-90 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Aurohealth LLC | 58602-913 | 58602-0913-1758602-0913-40 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-737 | 67877-0737-0167877-0737-0567877-0737-33+1 more |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-738 | 67877-0738-0167877-0738-0567877-0738-30+3 more |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-739 | 67877-0739-0167877-0739-0567877-0739-30+4 more |
Other NDCs under ANDA 202413
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 | Preferred Pharmaceuticals Inc. | 68788-8754 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8757 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-902 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2345 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2902 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-916 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3849 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-396 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-394 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-395 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4259 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-137 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | AiPing Pharmaceutical, Inc. | 11788-008 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | AiPing Pharmaceutical, Inc. | 11788-009 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | AiPing Pharmaceutical, Inc. | 11788-010 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3679 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7788 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-724 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7789 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2181 |
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