Over-the-counter drug · ANDA
Ibuprofen NDC 53746-462
Ibuprofen 200 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-462-02 | 53746046202 | 250 TABLET in 1 BOTTLE (53746-462-02)Marketed from Apr 30, 2013 | |
| 53746-462-10 | 53746046210 | 1000 TABLET in 1 BOTTLE (53746-462-10)Marketed from Apr 30, 2013 |
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
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079233
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 53746-462_0a178197-17b9-4e74-a85b-abd0ba469966SPL ID 0a178197-17b9-4e74-a85b-abd0ba469966SPL set ID 59f14d2b-f48a-4c25-bea3-3dc9100898b2RxCUI 310965UNII WK2XYI10QMUPC 0353746462022, 0353746458025, 0353746460028
- 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
N453746046202followed by a unit qualifier and the quantityPackage 53746-0462-02. 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)
Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079233
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.