SERTRALINE HYDROCHLORIDE
- Product NDC
- 50090-3203
- 11-digit product format
- 500903203
- Labeler code
- 50090
- Product ID
- 50090-3203_f61fd075-cfd8-468b-814a-2dd2dbb7d02d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202825
- Marketing category
- ANDA
- Marketing start
- 2017-02-09
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SERTRALINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-3203-0 | SERTRALINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
| 50090-3203-1 | SERTRALINE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 12 |
| 50090-3203-2 | SERTRALINE HYDROCHLORIDE | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3203 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 12 | Current NDC, Legacy NDC, 3 package rows | 20230511_14c4fa96-8919-4ea7-ad72-129f288d8cfc.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 |
|---|
| 50090-3203-0 | 50090320300 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-3203-0) | 2017-12-06 | 0000-00-00 | No | No | Current |
| 50090-3203-1 | 50090320301 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-3203-1) | 2017-10-23 | 0000-00-00 | No | No | Current |
| 50090-3203-2 | 50090320302 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3203-2) | 2017-02-09 | 0000-00-00 | No | No | Current |