Over-the-counter drug · ANDA
dual action pain reliever NDC 69452-446
acetaminophen and ibuprofen · Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 · Tablet, Film coated · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-446-23 | 69452044623 | 1 BOTTLE in 1 CARTON (69452-446-23) / 144 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 9, 2024 |
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)
- dual action pain reliever
- Generic name (nonproprietary)
- acetaminophen and ibuprofen
- Active ingredients
- Ibuprofen — 125 mg/1Acetaminophen — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bionpharma Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216999
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69452-446_1f470b1b-81aa-e59c-e063-6394a90a4055SPL ID 1f470b1b-81aa-e59c-e063-6394a90a4055SPL set ID 1f470b1b-81a9-e59c-e063-6394a90a4055RxCUI 2387532UNII WK2XYI10QM, 362O9ITL9D
- 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
N469452044623followed by a unit qualifier and the quantityPackage 69452-0446-23. 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: ■ backache ■ muscular aches ■ minor pain of arthritis ■ headache ■ toothache ■ menstrual cramps
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216999
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 |
|---|---|---|---|---|
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | AMERISOURCE BERGEN | 46122-742 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-394 |
| dual action pain relieveracetaminophen and ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-447 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | BIONPHARMA INC. | 69452-469 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | DISCOUNT DRUG MART, INC. | 53943-034 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | AMERISOURCE BERGEN | 46122-818 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 51316-955 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | WALGREEN COMPANY | 0363-4081 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 79481-6501 |
| dual action pain relieveracetaminophen and ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | CHAIN DRUG MARKETING ASSOCIATION INC. | 83324-149 |
| dual action pain relieveracetaminophen and ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | CHAIN DRUG MARKETING ASSOCIATION INC. | 83324-178 |