Sertraline Hydrochloride
- Product NDC
- 51655-173
- 11-digit product format
- 516550173
- Labeler code
- 51655
- Product ID
- 51655-173_48c3f247-fa03-787f-e063-6394a90a45c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2020-06-17
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sertraline Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTRALINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 312938 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-173-26 | Sertraline Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 4 |
| 51655-173-52 | Sertraline Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-173 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231109_ab0b0ef7-155b-cec9-e053-2a95a90a9fce.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 |
|---|
| 51655-173-26 | 51655017326 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-173-26) | 2020-07-14 | 0000-00-00 | No | No | Current |
| 51655-173-52 | 51655017352 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-173-52) | 2020-06-17 | 0000-00-00 | No | No | Current |