sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3203
Product ID 50090-3203_f61fd075-cfd8-468b-814a-2dd2dbb7d02d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202825
Listing Expiration 2026-12-31
Marketing Start 2017-02-09

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 500903203
Hyphenated Format 50090-3203

Supplemental Identifiers

RxCUI
312938
UNII
UTI8907Y6X

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 sertraline hydrochloride (source: ndc)
Generic Name sertraline hydrochloride (source: ndc)
Application Number ANDA202825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-3203-0)
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-3203-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3203-2)
source: ndc

Packages (3)

50090-3203-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-3203-0) 50090-3203-1 60 TABLET, FILM COATED in 1 BOTTLE (50090-3203-1) 50090-3203-2 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3203-2)

Ingredients (1)

sertraline hydrochloride (100 mg/1)

Linked Drug Pages (1)

SERTRALINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f61fd075-cfd8-468b-814a-2dd2dbb7d02d", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938"], "spl_set_id": ["14c4fa96-8919-4ea7-ad72-129f288d8cfc"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-3203-0)", "package_ndc": "50090-3203-0", "marketing_start_date": "20171206"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-3203-1)", "package_ndc": "50090-3203-1", "marketing_start_date": "20171023"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3203-2)", "package_ndc": "50090-3203-2", "marketing_start_date": "20170209"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "50090-3203_f61fd075-cfd8-468b-814a-2dd2dbb7d02d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50090-3203", "generic_name": "SERTRALINE HYDROCHLORIDE", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SERTRALINE HYDROCHLORIDE", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA202825", "marketing_category": "ANDA", "marketing_start_date": "20170209", "listing_expiration_date": "20261231"}