Prescription drug · ANDA
Ibuprofen NDC 85534-0013
Ibuprofen 800 mg/1 · Tablet · Oral · HAWAII REPACK, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85534-0013-0 | 85534001300 | 30 TABLET in 1 BOTTLE (85534-0013-0)Marketed from Jun 25, 2026 | |
| 85534-0013-1 | 85534001301 | 60 TABLET in 1 BOTTLE (85534-0013-1)Marketed from Jun 25, 2026 | |
| 85534-0013-2 | 85534001302 | 90 TABLET in 1 BOTTLE (85534-0013-2)Marketed from Jun 25, 2026 | |
| 85534-0013-3 | 85534001303 | 120 TABLET in 1 BOTTLE (85534-0013-3)Marketed from Jun 25, 2026 |
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 — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- HAWAII REPACK, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213794
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 85534-0013_55221d60-54df-9469-e063-6294a90a2f91SPL ID 55221d60-54df-9469-e063-6294a90a2f91SPL set ID 6239818c-747d-4cbb-9b41-27ca8bbce41bRxCUI 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
N485534001300followed by a unit qualifier and the quantityPackage 85534-0013-00. 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.
Other NDCs under ANDA 213794
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 | NorthStar Rx LLC | 72603-909 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | NorthStar Rx LLC | 72603-910 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2998 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-361 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-360 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-362 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-045 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-5435 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-5433 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5445 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5444 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2682 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5446 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3861 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2683 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2689 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3696 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4010 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-897 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4341 |
Showing 20 of 39.