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 25 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7396
Product ID 50090-7396_0e02192a-3e9f-4faf-b73c-fcb05d2bcc99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078403
Listing Expiration 2026-12-31
Marketing Start 2023-05-15

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 500907396
Hyphenated Format 50090-7396

Supplemental Identifiers

RxCUI
312940
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 ANDA078403 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-7396-0)
source: ndc

Packages (1)

50090-7396-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-7396-0)

Ingredients (1)

sertraline hydrochloride (25 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": "0e02192a-3e9f-4faf-b73c-fcb05d2bcc99", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312940"], "spl_set_id": ["f705f743-40e9-42bf-88f5-6dd7e5d5ba94"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-7396-0)", "package_ndc": "50090-7396-0", "marketing_start_date": "20241023"}], "brand_name": "Sertraline hydrochloride", "product_id": "50090-7396_0e02192a-3e9f-4faf-b73c-fcb05d2bcc99", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50090-7396", "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": "25 mg/1"}], "application_number": "ANDA078403", "marketing_category": "ANDA", "marketing_start_date": "20230515", "listing_expiration_date": "20261231"}