eight hour pain relief
- Product NDC
- 41163-203
- 11-digit product format
- 411630203
- Labeler code
- 41163
- Product ID
- 41163-203_fbe58138-8e22-c4d9-e053-6294a90a3bd0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- United Natural Foods, Inc. dba UNFI
- Application
- ANDA211544
- Marketing category
- ANDA
- Marketing start
- 2022-04-29
- 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
- eight hour pain relief
- 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 |
|---|
| 41163-203-02 | eight hour pain relief | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 4 |
| 41163-203-02 | eight hour pain relief | 50 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 50 | | 4 |
| 41163-203-03 | eight hour pain relief | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 4 |
| 41163-203-03 | eight hour pain relief | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41163-203 | EIGHT HOUR PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230519_b5fe8873-13c9-402e-b06c-6e679af7267e.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 |
|---|
| 41163-203-02 | 41163020302 | 1 BOTTLE, PLASTIC in 1 CARTON (41163-203-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | 2022-04-29 | 0000-00-00 | No | No | Current |
| 41163-203-03 | 41163020303 | 1 BOTTLE, PLASTIC in 1 CARTON (41163-203-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | 2022-08-01 | 0000-00-00 | No | No | Current |