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 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7661
Product ID 50090-7661_66ca5c23-a5b3-49eb-8f17-ef7ab9dec544
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077670
Listing Expiration 2027-12-31
Marketing Start 2025-08-06

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 500907661
Hyphenated Format 50090-7661

Supplemental Identifiers

RxCUI
312941
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 ANDA077670 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-7661-0)
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-7661-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-7661-2)
source: ndc

Packages (3)

50090-7661-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-7661-0) 50090-7661-1 60 TABLET, FILM COATED in 1 BOTTLE (50090-7661-1) 50090-7661-2 90 TABLET, FILM COATED in 1 BOTTLE (50090-7661-2)

Ingredients (1)

sertraline hydrochloride (50 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": "66ca5c23-a5b3-49eb-8f17-ef7ab9dec544", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312941"], "spl_set_id": ["b5e98b93-d8f8-4eed-8a0a-63b347b670ed"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-7661-0)", "package_ndc": "50090-7661-0", "marketing_start_date": "20250929"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-7661-1)", "package_ndc": "50090-7661-1", "marketing_start_date": "20250929"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-7661-2)", "package_ndc": "50090-7661-2", "marketing_start_date": "20250929"}], "brand_name": "Sertraline Hydrochloride", "product_id": "50090-7661_66ca5c23-a5b3-49eb-8f17-ef7ab9dec544", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50090-7661", "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": "50 mg/1"}], "application_number": "ANDA077670", "marketing_category": "ANDA", "marketing_start_date": "20250806", "listing_expiration_date": "20271231"}