Acetaminophen
- Product NDC
- 49483-699
- 11-digit product format
- 494830699
- Labeler code
- 49483
- Product ID
- 49483-699_02a5f067-4b67-ecc7-e063-6294a90a92c3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen tablet extended release
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC.
- Application
- ANDA215486
- Marketing category
- ANDA
- Marketing start
- 2021-10-04
- 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
- 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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49483-699-01 | Acetaminophen | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 3 |
| 49483-699-05 | Acetaminophen | 50 in 1 CARTON | TABLET, EXTENDED RELEASE | 50 | | 3 |
| 49483-699-05 | Acetaminophen | 1 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1 | | 3 |
| 49483-699-26 | Acetaminophen | 225 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 225 | | 3 |
| 49483-699-40 | Acetaminophen | 400 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 400 | | 3 |
| 49483-699-42 | Acetaminophen | 24 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 24 | | 3 |
| 49483-699-42 | Acetaminophen | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-699 | ACETAMINOPHEN (ACETAMINOPHEN TABLET EXTENDED RELEASE) TABLET, EXTENDED RELEASE MUSCLE ACHES AND PAINS ACETAMINOPHEN EXTENDED RELEASE (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [TIME CAP LABORATORIES, INC.] | 3 | Current NDC, Legacy NDC, 7 package rows | 20240320_cd4d0ad4-7206-94c8-e053-2a95a90aaa14.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 |
|---|
| 49483-699-01 | 49483069901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-01) | | 2021-10-04 | 0000-00-00 | No | No | Current |
| 49483-699-05 | 49483069905 | 50 BOTTLE in 1 CARTON (49483-699-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE | 50 bottle | 2021-10-04 | 0000-00-00 | No | No | Current |
| 49483-699-26 | 49483069926 | 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-26) | | 2022-11-07 | 0000-00-00 | No | No | Current |
| 49483-699-40 | 49483069940 | 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40) | | 2021-10-04 | 0000-00-00 | No | No | Current |
| 49483-699-42 | 49483069942 | 1 BOTTLE in 1 CARTON (49483-699-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2022-11-07 | 0000-00-00 | No | No | Current |