Acetaminophen
- Product NDC
- 63868-660
- 11-digit product format
- 638680660
- Labeler code
- 63868
- Product ID
- 63868-660_459b55dd-858e-ce9f-e063-6394a90a17d1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CHAIN DRUG MARKETING ASSOCIATION INC
- Application
- ANDA211544
- Marketing category
- ANDA
- Marketing start
- 2020-08-01
- Marketing end
- 2026-12-31
- Substance
- ACETAMINOPHEN
- Active strength
- 650 mg/1
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen
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 |
|---|
| 63868-660-01 | Acetaminophen | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 5 |
| 63868-660-22 | Acetaminophen | 225 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 225 | | 5 |
| 63868-660-50 | Acetaminophen | 1 in 1 PACKAGE | TABLET, EXTENDED RELEASE | 1 | | 5 |
| 63868-660-50 | Acetaminophen | 50 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63868-660 | ACETAMINOPHEN TABLET, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20241013_2e30754a-42f7-4da2-944c-be61cee47b43.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63868-660-01 | 63868066001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63868-660-01) | 2020-08-01 | 2026-12-31 | No | No | Current |
| 63868-660-22 | 63868066022 | 225 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63868-660-22) | 2020-08-01 | 0000-00-00 | No | No | Current |
| 63868-660-50 | 63868066050 | 1 BOTTLE, PLASTIC in 1 PACKAGE (63868-660-50) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | 2020-08-01 | 2026-12-31 | No | No | Current |