sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 100 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0310
Product ID 80425-0310_2a9bfe6a-6d6c-b262-e063-6294a90a1cf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077206
Listing Expiration 2026-12-31
Marketing Start 2023-04-07

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 804250310
Hyphenated Format 80425-0310

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 hydrochloride (source: ndc)
Generic Name sertraline hydrochloride (source: ndc)
Application Number ANDA077206 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0310-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0310-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0310-3)
source: ndc

Packages (3)

80425-0310-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0310-1) 80425-0310-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0310-2) 80425-0310-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0310-3)

Ingredients (1)

sertraline hydrochloride (100 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": "2a9bfe6a-6d6c-b262-e063-6294a90a1cf3", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938"], "spl_set_id": ["f8c45a99-18ed-0e1f-e053-6394a90a2d52"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0310-1)", "package_ndc": "80425-0310-1", "marketing_start_date": "20230407"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0310-2)", "package_ndc": "80425-0310-2", "marketing_start_date": "20230407"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0310-3)", "package_ndc": "80425-0310-3", "marketing_start_date": "20230407"}], "brand_name": "Sertraline Hydrochloride", "product_id": "80425-0310_2a9bfe6a-6d6c-b262-e063-6294a90a1cf3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "80425-0310", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA077206", "marketing_category": "ANDA", "marketing_start_date": "20230407", "listing_expiration_date": "20261231"}