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 | 2500000800725000008007 | 1 BOTTLE in 1 CARTON (25000-080-07) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 11, 2023 | |
| 25000-080-72 | 2500000807225000008072 | 1 BOTTLE in 1 CARTON (25000-080-72) / 18 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 11, 2023 | |
| 25000-080-74 | 2500000807425000008074 | 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 LIMITEDNDC labeler code 25000
- 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.
About NDC 25000-080
- What is NDC 25000-080?
- 25000-080 is the product NDC for Acetaminophen 250 mg and Ibuprofen 125 mg, Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 tablet, film coated, listed with the FDA by MARKSANS PHARMA LIMITED. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen 250 mg and Ibuprofen 125 mg (Acetaminophen 250 mg and Ibuprofen 125 mg Tablets).
- What is the active ingredient?
- Acetaminophen, Ibuprofen.
- Who is the labeler?
- MARKSANS PHARMA LIMITED, NDC labeler code 25000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen 250 mg and Ibuprofen 125 mg?
- 3 other product NDCs are listed under this name. See all Acetaminophen 250 mg and Ibuprofen 125 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen 250 mg and Ibuprofen 125 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetaminophen 250 mg and Ibuprofen 125 mgacetaminophen 250 mg and ibuprofen 125 mg tablets | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4258 | 51672-4258-0151672-4258-04 |
| 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 | 43598-0052-0543598-0052-1443598-0052-18+2 more |
| Acetaminophen 250 mg and Ibuprofen 125 mg | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | R J General Corporation | 70264-040 | 70264-0040-12 |
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 Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-716 |
| Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | KROGER COMPANY | 41226-716 |
| Dual Action Pain Reliefacetaminophen, ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | TARGET CORPORATION | 11673-924 |
| Dual Action Pain Reliefacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-716 |