Over-the-counter drug · ANDA
Acetaminophen 250 mg and Ibuprofen 125 mg NDC 25000-080
acetaminophen 250 mg and ibuprofen 125 mg tablets · Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 · Tablet, Film coated · Oral · MARKSANS PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25000-080-07 | 25000008007 | 1 BOTTLE in 1 CARTON (25000-080-07) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 11, 2023 | |
| 25000-080-72 | 25000008072 | 1 BOTTLE in 1 CARTON (25000-080-72) / 18 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 11, 2023 | |
| 25000-080-74 | 25000008074 | 288 TABLET, FILM COATED in 1 BOTTLE (25000-080-74)Marketed 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)
- Acetaminophen 250 mg and Ibuprofen 125 mg
- Generic name (nonproprietary)
- acetaminophen 250 mg and ibuprofen 125 mg tablets
- Active ingredients
- Acetaminophen — 250 mg/1Ibuprofen — 125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- MARKSANS PHARMA LIMITED
- 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 25000-080_38a01bed-7a8b-4aed-97c1-cc1545f76f79SPL ID 38a01bed-7a8b-4aed-97c1-cc1545f76f79SPL set ID 46121a30-1361-4f2b-9f3f-3cedabd66c33RxCUI 2387532UNII 362O9ITL9D, WK2XYI10QMUPC 0325000080723, 0325000080075, 0325000080747
- 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
N425000008007followed by a unit qualifier and the quantityPackage 25000-0080-07. 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: o headache o toothache o backache o menstrual cramps o muscular aches o 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 |
| Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-716 |
| 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 | KROGER COMPANY | 41226-716 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.