Acetaminophen 250 mg and Ibuprofen 125 mg
- Product NDC
- 25000-080
- 11-digit product format
- 250000080
- Labeler code
- 25000
- Product ID
- 25000-080_38a01bed-7a8b-4aed-97c1-cc1545f76f79
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA216994
- Marketing category
- ANDA
- Marketing start
- 2023-07-11
- Substance
- ACETAMINOPHEN; IBUPROFEN
- Active strength
- 250; 125 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen 250 mg and Ibuprofen 125 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 250 mg/1 |
| IBUPROFEN | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, WK2XYI10QM |
| Rxcui | 2387532 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-080-07 | Acetaminophen 250 mg and Ibuprofen 125 mg | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
| 25000-080-07 | Acetaminophen 250 mg and Ibuprofen 125 mg | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 25000-080-72 | Acetaminophen 250 mg and Ibuprofen 125 mg | 18 in 1 BOTTLE | TABLET, FILM COATED | 18 | | 6 |
| 25000-080-72 | Acetaminophen 250 mg and Ibuprofen 125 mg | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 25000-080-74 | Acetaminophen 250 mg and Ibuprofen 125 mg | 288 in 1 BOTTLE | TABLET, FILM COATED | 288 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25000-080 | ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG (ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETS) TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 5 | Current NDC, 5 package rows | 20230712_46121a30-1361-4f2b-9f3f-3cedabd66c33.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25000-080-07 | 25000008007 | 1 BOTTLE in 1 CARTON (25000-080-07) / 90 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2023-07-11 | No | No | Current |
| 25000-080-72 | 25000008072 | 1 BOTTLE in 1 CARTON (25000-080-72) / 18 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2023-07-11 | No | No | Current |
| 25000-080-74 | 25000008074 | 288 TABLET, FILM COATED in 1 BOTTLE (25000-080-74) | | 2023-07-11 | No | No | Current |