sertraline

Generic: sertraline

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline
Generic Name sertraline
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 100 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2411
Product ID 72162-2411_f2da9a9d-f2dd-474e-a81e-dfbecd4d78b9
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 721622411
Hyphenated Format 72162-2411

Supplemental Identifiers

RxCUI
312938
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
  • 100 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72162-2411-0)
  • 100 TABLET, FILM COATED in 1 BOTTLE (72162-2411-1)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72162-2411-5)
source: ndc

Packages (3)

Ingredients (1)

sertraline hydrochloride (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "f2da9a9d-f2dd-474e-a81e-dfbecd4d78b9", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938"], "spl_set_id": ["e0adb991-ec4e-4cd1-b54e-6d8c731a1d59"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72162-2411-0)", "package_ndc": "72162-2411-0", "marketing_start_date": "20241030"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72162-2411-1)", "package_ndc": "72162-2411-1", "marketing_start_date": "20241030"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72162-2411-5)", "package_ndc": "72162-2411-5", "marketing_start_date": "20241030"}], "brand_name": "Sertraline", "product_id": "72162-2411_f2da9a9d-f2dd-474e-a81e-dfbecd4d78b9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72162-2411", "generic_name": "Sertraline", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA076465", "marketing_category": "ANDA", "marketing_start_date": "20230223", "listing_expiration_date": "20261231"}