Prescription drug · ANDA
Ibuprofen NDC 70518-4595
Ibuprofen 100 mg/5mL · Suspension · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4595-0 | 70518459500 | 1 BOTTLE in 1 CARTON (70518-4595-0) / 118 mL in 1 BOTTLEMarketed from Mar 24, 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 — 100 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209204
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-4595_4dc63099-bda6-c9ae-e063-6394a90af398SPL ID 4dc63099-bda6-c9ae-e063-6394a90af398SPL set ID dda7645f-1666-4c1f-b974-01add2ea79acRxCUI 197803UNII 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
N470518459500followed by a unit qualifier and the quantityPackage 70518-4595-00. 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 oral suspension 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 ). In Pediatric Patients, Ibuprofen Oral Suspension is indicated: For reduction of fever in patients aged 6 months up to 2 years of age. For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. For relief of signs and symptoms of juvenile arthritis. In Adults, Ibuprofen Oral Suspension is indicated: For treatment of primary dysmenorrhea. For relief of the signs and symptoms of rheumat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209204
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.