Over-the-counter drug · ANDA
Ibuprofen NDC 69168-466
Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · Allegiant Health
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-466-05 | 69168046605 | 500 TABLET, FILM COATED in 1 BOTTLE (69168-466-05)Marketed from Apr 16, 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 — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Allegiant Health
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207095
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69168-466_198de88b-950e-449d-9221-5fa557c8b007SPL ID 198de88b-950e-449d-9221-5fa557c8b007SPL set ID 2ea039d6-f522-4103-a1f9-5b80a3b12a27RxCUI 310965UNII 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
N469168046605followed by a unit qualifier and the quantityPackage 69168-0466-05. 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 .
Indications (excerpt from the label)
Use(s) temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches n minor pain of arthritis temporarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207095
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 200 mg/1 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0049 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0165 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | PROSTAT FIRST AID | 58228-6185 |
| Ibuprofen 200mg | Ibuprofen 200 mg/1 | TabletOral | Allegiant Health | 69168-467 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Trifecta Pharmaceuticals USA LLC | 69396-141 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Trifecta Pharmaceuticals USA LLC | 69396-145 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Trifecta Pharmaceuticals USA LLC | 69396-172 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0020 |