Over-the-counter drug · ANDA
Dual Action NDC 41226-716
acetaminophen, ibuprofen · Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 · Tablet · Oral · KROGER COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41226-716-49 | 41226071649 | 1 BOTTLE in 1 CARTON (41226-716-49) / 144 TABLET in 1 BOTTLEMarketed from Jul 11, 2023 |
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, ibuprofen
- Active ingredients
- Acetaminophen — 250 mg/1Ibuprofen — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- KROGER COMPANY
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216994
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 41226-716_002fdf94-eba4-9115-e063-6294a90a1582SPL ID 002fdf94-eba4-9115-e063-6294a90a1582SPL set ID ee0ae5e6-388d-0085-e053-2a95a90add8eRxCUI 2387532UNII 362O9ITL9D, WK2XYI10QMUPC 0041260019012
- 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
N441226071649followed by a unit qualifier and the quantityPackage 41226-0716-49. 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 toothache backache menstrual cramps muscular aches minor pain of arthritis
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216994
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 |
|---|---|---|---|---|
| Dual Action Pain Reliefacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-716 |
| Acetaminophen 250 mg and Ibuprofen 125 mgacetaminophen 250 mg and ibuprofen 125 mg tablets | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | MARKSANS PHARMA LIMITED | 25000-080 |
| Dual Action Pain Reliefacetaminophen, ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | TARGET CORPORATION | 11673-924 |
| Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-716 |