sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: sciegen pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler sciegen pharmaceuticals inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 25 mg/1

Manufacturer
ScieGen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 50228-467
Product ID 50228-467_09a95635-597e-d608-e063-6294a90a203f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076442
Listing Expiration 2026-12-31
Marketing Start 2023-05-08

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 50228467
Hyphenated Format 50228-467

Supplemental Identifiers

RxCUI
312938 312940 312941
UPC
0350228469302 0350228468305 0350228469906 0350228468053 0350228467056 0350228467308 0350228469050 0350228468909 0350228467902
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 sertraline hydrochloride (source: ndc)
Generic Name sertraline hydrochloride (source: ndc)
Application Number ANDA076442 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-90)
source: ndc

Packages (3)

50228-467-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-05) 50228-467-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-30) 50228-467-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-90)

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": "09a95635-597e-d608-e063-6294a90a203f", "openfda": {"upc": ["0350228469302", "0350228468305", "0350228469906", "0350228468053", "0350228467056", "0350228467308", "0350228469050", "0350228468909", "0350228467902"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["10b9cae4-b452-4abb-866a-9f9d2568f212"], "manufacturer_name": ["ScieGen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-05)", "package_ndc": "50228-467-05", "marketing_start_date": "20230508"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-30)", "package_ndc": "50228-467-30", "marketing_start_date": "20230508"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-90)", "package_ndc": "50228-467-90", "marketing_start_date": "20230508"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "50228-467_09a95635-597e-d608-e063-6294a90a203f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50228-467", "generic_name": "SERTRALINE HYDROCHLORIDE", "labeler_name": "ScieGen Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SERTRALINE HYDROCHLORIDE", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA076442", "marketing_category": "ANDA", "marketing_start_date": "20230508", "listing_expiration_date": "20261231"}