sertraline

Generic: sertraline

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline
Generic Name sertraline
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 25 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-757
Product ID 23155-757_5079a5d2-af51-4bac-aaad-75653da2aa97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076465
Listing Expiration 2026-12-31
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 23155757
Hyphenated Format 23155-757

Supplemental Identifiers

RxCUI
312938 312940 312941
UPC
0323155757057 0323155758054 0323155759051 0323155759037 0323155758030
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 (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 (23155-757-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE (23155-757-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE (23155-757-09)
source: ndc

Packages (3)

23155-757-03 30 TABLET, FILM COATED in 1 BOTTLE (23155-757-03) 23155-757-05 500 TABLET, FILM COATED in 1 BOTTLE (23155-757-05) 23155-757-09 90 TABLET, FILM COATED in 1 BOTTLE (23155-757-09)

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": "5079a5d2-af51-4bac-aaad-75653da2aa97", "openfda": {"upc": ["0323155757057", "0323155758054", "0323155759051", "0323155759037", "0323155758030"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["444ca054-e450-4c10-a31b-71ad43946cb8"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (23155-757-03)", "package_ndc": "23155-757-03", "marketing_start_date": "20230223"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (23155-757-05)", "package_ndc": "23155-757-05", "marketing_start_date": "20230223"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (23155-757-09)", "package_ndc": "23155-757-09", "marketing_start_date": "20230223"}], "brand_name": "Sertraline", "product_id": "23155-757_5079a5d2-af51-4bac-aaad-75653da2aa97", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "23155-757", "generic_name": "Sertraline", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "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": "20261231"}