Over-the-counter drug · ANDA
Dual Action NDC 75907-158
acetaminophen and ibuprofen (nsaid) tablets, 250 mg/ 125 mg · Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 · Tablet, Film coated · Oral · Dr. Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-158-14 | 75907015814 | 144 TABLET, FILM COATED in 1 BOTTLE (75907-158-14)Marketed from Feb 6, 2025 | |
| 75907-158-25 | 75907015825 | 250 TABLET, FILM COATED in 1 BOTTLE (75907-158-25)Marketed from Feb 6, 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)
- Dual Action
- Generic name (nonproprietary)
- acetaminophen and ibuprofen (nsaid) tablets, 250 mg/ 125 mg
- Active ingredients
- Ibuprofen — 125 mg/1Acetaminophen — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories Inc
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218247
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 75907-158_ac5bcacf-74a8-2803-2157-fa190e092558SPL ID ac5bcacf-74a8-2803-2157-fa190e092558SPL set ID c8a8a18a-6766-37a9-d0f0-f9380fb5b0e8RxCUI 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
N475907015814followed by a unit qualifier and the quantityPackage 75907-0158-14. 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 Uses • temporarily relieves minor aches and pains due to: • headache • toothache • backache • menstrual cramps • muscular aches • minor pain of arthritis
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218247
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 250 mg and Ibuprofen 125 mgacetaminophen and ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Labortories Inc | 43598-052 |