Acetaminophen Extended-Release
- Product NDC
- 54257-573
- 11-digit product format
- 542570573
- Labeler code
- 54257
- Product ID
- 54257-573_cf6e6c2c-3775-f475-e053-2995a90a2754
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Magno-Humphries, Inc.
- Application
- ANDA211544
- Marketing category
- ANDA
- Marketing start
- 2020-01-24
- 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
- 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 |
|---|
| 54257-573-02 | Acetaminophen Extended-Release | 200 in 1 BOTTLE | TABLET | 200 | | 4 |
| 54257-573-03 | Acetaminophen Extended-Release | 200 in 1 BOTTLE | TABLET | 200 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54257-573 | ACETAMINOPHEN EXTENDED-RELEASE (ACETAMINOPHEN) TABLET [MAGNO-HUMPHRIES, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20211030_9d22bedb-9fc9-8421-e053-2a95a90acf4a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54257-573-02 | 54257057302 | 200 in 1 BOTTLE | | | | | | Historical |
| 54257-573-03 | 54257057303 | 200 TABLET in 1 BOTTLE (54257-573-03) | 200 tablet | 2020-01-24 | 0000-00-00 | No | No | Current |