Sertraline hydrochloride
- Product NDC
- 59762-0067
- 11-digit product format
- 597620067
- Labeler code
- 59762
- Product ID
- 59762-0067_a0edcebe-af2d-463c-aad8-fa5fb77f0828
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline hydrochloride
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA020990
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-05-15
- 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 |
|---|
| 59762-0067-1 | Sertraline hydrochloride | 1 in 1 CARTON | SOLUTION, CONCENTRATE | 1 | | 41 |
| 59762-0067-1 | Sertraline hydrochloride | 60 mL in 1 BOTTLE, DROPPER | SOLUTION, CONCENTRATE | 60 | | 41 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| MENTHOL, UNSPECIFIED FORM | INACTIVE INGREDIENT | L7T10EIP3A | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] | 24 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59762-0067 | SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [MYLAN PHARMACEUTICALS INC.] | 41 | Current NDC, Legacy NDC, 2 package rows | 20250504_1a58062b-e635-431a-908d-2651c6a4a21c.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 |
|---|
| 59762-0067-1 | 59762006701 | 1 BOTTLE, DROPPER in 1 CARTON (59762-0067-1) / 60 mL in 1 BOTTLE, DROPPER | 2018-05-15 | 0000-00-00 | No | No | Current |