sertraline

Generic: sertraline

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

sertraline hydrochloride 50 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-213
Product ID 76282-213_5c34aa64-3f25-4d6e-8fbb-98aa3688f72d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077397
Listing Expiration 2026-12-31
Marketing Start 2012-08-20

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 76282213
Hyphenated Format 76282-213

Supplemental Identifiers

RxCUI
312938 312940 312941
UPC
0376282214306 0376282212302 0376282213309
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 ANDA077397 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76282-213-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76282-213-05)
  • 180 TABLET, FILM COATED in 1 BOTTLE (76282-213-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76282-213-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76282-213-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76282-213-90)
source: ndc

Packages (6)

76282-213-01 100 TABLET, FILM COATED in 1 BOTTLE (76282-213-01) 76282-213-05 500 TABLET, FILM COATED in 1 BOTTLE (76282-213-05) 76282-213-18 180 TABLET, FILM COATED in 1 BOTTLE (76282-213-18) 76282-213-30 30 TABLET, FILM COATED in 1 BOTTLE (76282-213-30) 76282-213-60 60 TABLET, FILM COATED in 1 BOTTLE (76282-213-60) 76282-213-90 90 TABLET, FILM COATED in 1 BOTTLE (76282-213-90)

Ingredients (1)

sertraline hydrochloride (50 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": "5c34aa64-3f25-4d6e-8fbb-98aa3688f72d", "openfda": {"upc": ["0376282214306", "0376282212302", "0376282213309"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["2dac437f-b5ef-42dd-aa0b-1f4b9b45ef43"], "manufacturer_name": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76282-213-01)", "package_ndc": "76282-213-01", "marketing_start_date": "20120820"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76282-213-05)", "package_ndc": "76282-213-05", "marketing_start_date": "20120820"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (76282-213-18)", "package_ndc": "76282-213-18", "marketing_start_date": "20120820"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76282-213-30)", "package_ndc": "76282-213-30", "marketing_start_date": "20120820"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76282-213-60)", "package_ndc": "76282-213-60", "marketing_start_date": "20120820"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76282-213-90)", "package_ndc": "76282-213-90", "marketing_start_date": "20120820"}], "brand_name": "SERTRALINE", "product_id": "76282-213_5c34aa64-3f25-4d6e-8fbb-98aa3688f72d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "76282-213", "generic_name": "Sertraline", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SERTRALINE", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA077397", "marketing_category": "ANDA", "marketing_start_date": "20120820", "listing_expiration_date": "20261231"}