Prescription drug · ANDA
Ibuprofen NDC 70518-4259
Ibuprofen 800 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4259-0 | 70518425900 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4259-0)Marketed from Jan 22, 2025 | |
| 70518-4259-2 | 70518425902 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4259-2)Marketed from Apr 17, 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, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- 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 70518-4259_5a70eda1-3cc1-db88-e063-6394a90ad3e7SPL ID 5a70eda1-3cc1-db88-e063-6394a90ad3e7SPL set ID 404df13d-4ada-4324-9eed-e21f5d5043a4RxCUI 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
N470518425900followed by a unit qualifier and the quantityPackage 70518-4259-00. 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 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 400 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-394 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3849 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7905 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-137 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3121 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-565 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-584 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-590 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2184 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Brisk Pharmaceuticals | 73614-201 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2181 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2184 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3679 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2196 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4039 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-844 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0553 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | PHOENIX RX LLC | 85509-2396 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-227 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3966 |
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