Prescription drug · ANDA
Ibuprofen NDC 73614-201
Ibuprofen 800 mg/1 · Tablet, Film coated · Oral · Brisk Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73614-201-03 | 73614020103 | 30 TABLET, FILM COATED in 1 BOTTLE (73614-201-03)Marketed from Feb 10, 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
- Brisk Pharmaceuticals
- 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 73614-201_2dcbe4bb-fb23-e827-e063-6394a90acf9fSPL ID 2dcbe4bb-fb23-e827-e063-6394a90acf9fSPL set ID 2dcbe4bb-fb24-e827-e063-6394a90acf9fRxCUI 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
N473614020103followed by a unit qualifier and the quantityPackage 73614-0201-03. 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 800 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4259 |
| 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 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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