Medline
- Product NDC
- 53329-197
- 11-digit product format
- 533290197
- Labeler code
- 53329
- Product ID
- 53329-197_1cd8105b-61d9-1400-e063-6394a90a8422
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Medline Industries, LP
- Application
- ANDA211544
- Marketing category
- ANDA
- Marketing start
- 2024-07-01
- 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
- Medline
- 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 |
|---|
| 53329-197-29 | Medline | 50 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53329-197 | MEDLINE (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MEDLINE INDUSTRIES, LP] | 3 | Current NDC, 1 package rows | 20240711_fc5fb080-bb9b-3283-e053-6394a90aabfb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 53329-197-29 | 53329019729 | 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (53329-197-29) | 2024-07-01 | No | No | Current |