Acetaminophen
- Product NDC
- 0363-9604
- 11-digit product format
- 003639604
- Labeler code
- 0363
- Product ID
- 0363-9604_e6c2e68f-9711-4b57-b72b-ece33e19edc6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- WALGREEN CO.
- Application
- ANDA207229
- Marketing category
- ANDA
- Marketing start
- 2021-07-07
- 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0363-9604-07 | Acetaminophen | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 7 |
| 0363-9604-07 | Acetaminophen | 24 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 24 | | 7 |
| 0363-9604-35 | Acetaminophen | 225 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 225 | | 7 |
| 0363-9604-35 | Acetaminophen | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-9604 | ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN CO.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240510_c20d110a-ed5e-aed4-e053-2a95a90a4200.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 |
|---|
| 0363-9604-07 | 00363960407 | 1 BOTTLE in 1 CARTON (0363-9604-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2021-07-07 | 0000-00-00 | No | No | Current |
| 0363-9604-35 | 00363960435 | 1 BOTTLE in 1 CARTON (0363-9604-35) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2021-07-07 | 0000-00-00 | No | No | Current |