Acetaminophen Extended-Release Tablets, 650 mg
- Product NDC
- 25000-108
- 11-digit product format
- 250000108
- Labeler code
- 25000
- Product ID
- 25000-108_9e2c09cd-1bd4-4a86-8911-ba904d8a76cb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA215486
- Marketing category
- ANDA
- Marketing start
- 2022-10-14
- Substance
- ACETAMINOPHEN
- Active strength
- 650 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen Extended-Release Tablets, 650 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D |
| Rxcui | 1148399 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-108-02 | Acetaminophen Extended-Release Tablets, 650 mg | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 5 |
| 25000-108-02 | Acetaminophen Extended-Release Tablets, 650 mg | 24 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 24 | | 5 |
| 25000-108-08 | Acetaminophen Extended-Release Tablets, 650 mg | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 5 |
| 25000-108-08 | Acetaminophen Extended-Release Tablets, 650 mg | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25000-108 | ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MARKSANS PHARMA LIMITED] | 5 | Current NDC, 4 package rows | 20231019_d973a910-5fe0-4a85-884d-2c3987836691.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 |
|---|
| 25000-108-02 | 25000010802 | 1 BOTTLE in 1 CARTON (25000-108-02) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2022-10-14 | No | No | Current |
| 25000-108-08 | 25000010808 | 1 BOTTLE in 1 CARTON (25000-108-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2022-10-14 | No | No | Current |