sertraline

Generic: sertraline

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

Drug Facts

Product Profile

Brand Name sertraline
Generic Name sertraline
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 50090-7614
Product ID 50090-7614_259c0788-adb3-464a-bcb8-59009ebe04f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076465
Listing Expiration 2027-12-31
Marketing Start 2023-02-23

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 500907614
Hyphenated Format 50090-7614

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 (source: ndc)
Generic Name sertraline (source: ndc)
Application Number ANDA076465 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-7614-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-7614-1)
source: ndc

Packages (2)

50090-7614-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-7614-0) 50090-7614-1 90 TABLET, FILM COATED in 1 BOTTLE (50090-7614-1)

Ingredients (1)

sertraline hydrochloride (25 mg/1)

Linked Drug Pages (1)

Sertraline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "259c0788-adb3-464a-bcb8-59009ebe04f6", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312940"], "spl_set_id": ["e46bc887-69e2-4037-be59-6513277d157b"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-7614-0)", "package_ndc": "50090-7614-0", "marketing_start_date": "20250723"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-7614-1)", "package_ndc": "50090-7614-1", "marketing_start_date": "20250723"}], "brand_name": "Sertraline", "product_id": "50090-7614_259c0788-adb3-464a-bcb8-59009ebe04f6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50090-7614", "generic_name": "Sertraline", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA076465", "marketing_category": "ANDA", "marketing_start_date": "20230223", "listing_expiration_date": "20271231"}