zoloft

Generic: sertraline hydrochloride

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zoloft
Generic Name sertraline hydrochloride
Labeler viatris specialty llc
Dosage Form SOLUTION, CONCENTRATE
Routes
ORAL
Active Ingredients

sertraline hydrochloride 20 mg/mL

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-601
Product ID 58151-601_fd27d2f5-1ade-4dbf-b2d2-bb98daf7da3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020990
Listing Expiration 2026-12-31
Marketing Start 2024-11-21

Pharmacologic Class

Classes
cytochrome p450 2d6 inhibitors [moa] serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58151601
Hyphenated Format 58151-601

Supplemental Identifiers

RxCUI
208149 208161 212233 312938 312940 312941 861064 861066
UNII
UTI8907Y6X

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zoloft (source: ndc)
Generic Name sertraline hydrochloride (source: ndc)
Application Number NDA020990 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (58151-601-35) / 60 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

58151-601-35 1 BOTTLE, DROPPER in 1 CARTON (58151-601-35) / 60 mL in 1 BOTTLE, DROPPER

Ingredients (1)

sertraline hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Zoloft ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fd27d2f5-1ade-4dbf-b2d2-bb98daf7da3a", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["208149", "208161", "212233", "312938", "312940", "312941", "861064", "861066"], "spl_set_id": ["fda754f6-d0f3-4dce-a17a-927d64f912f7"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (58151-601-35)  / 60 mL in 1 BOTTLE, DROPPER", "package_ndc": "58151-601-35", "marketing_start_date": "20241121"}], "brand_name": "Zoloft", "product_id": "58151-601_fd27d2f5-1ade-4dbf-b2d2-bb98daf7da3a", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "58151-601", "generic_name": "sertraline hydrochloride", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zoloft", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "NDA020990", "marketing_category": "NDA", "marketing_start_date": "20241121", "listing_expiration_date": "20261231"}