Sertraline Hydrochloride
- Product NDC
- 64980-409
- 11-digit product format
- 649800409
- Labeler code
- 64980
- Product ID
- 64980-409_eccbd1a5-caba-4b22-b964-95ccb8dadeac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA078861
- Marketing category
- ANDA
- Marketing start
- 2008-10-31
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UTI8907Y6X |
| Rxcui | 861064 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64980-409-06 | Sertraline Hydrochloride | 60 mL in 1 BOTTLE, PLASTIC | SOLUTION, CONCENTRATE | 60 | | 12 |
| 64980-409-06 | Sertraline Hydrochloride | 1 in 1 CARTON | SOLUTION, CONCENTRATE | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-409 | SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [RISING PHARMA HOLDINGS, INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240703_af2c75a3-131e-4bde-83fd-310fd2c01161.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 |
|---|
| 64980-409-06 | 64980040906 | 1 BOTTLE, PLASTIC in 1 CARTON (64980-409-06) / 60 mL in 1 BOTTLE, PLASTIC | 2008-10-31 | 0000-00-00 | No | No | Current |