Sertraline
- Product NDC
- 55700-225
- 11-digit product format
- 557000225
- Labeler code
- 55700
- Product ID
- 55700-225_e5bbd1ab-183b-4c52-ac67-32693703e459
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA077670
- Marketing category
- ANDA
- Marketing start
- 2015-02-27
- Marketing end
- 2027-05-31
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sertraline
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55700-225-30 | Sertraline | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55700-225 | SERTRALINE TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20241219_6ed2b9b7-e4af-4e28-a7d5-4ccb514af217.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 |
|---|
| 55700-225-30 | 55700022530 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-225-30) | 2015-02-27 | 2027-05-31 | No | No | Historical |