sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-435
Product ID 71610-435_730d7b7d-3846-47b2-b527-c2bb233f8052
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077206
Listing Expiration 2026-12-31
Marketing Start 2007-02-06

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610435
Hyphenated Format 71610-435

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
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-435-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-435-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-435-60)
  • 135 TABLET, FILM COATED in 1 BOTTLE (71610-435-73)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-435-80)
source: ndc

Packages (5)

71610-435-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-435-45) 71610-435-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-435-53) 71610-435-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-435-60) 71610-435-73 135 TABLET, FILM COATED in 1 BOTTLE (71610-435-73) 71610-435-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-435-80)

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": "730d7b7d-3846-47b2-b527-c2bb233f8052", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938"], "spl_set_id": ["e815c67d-951c-4cb3-a840-f0b493b97da1"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-435-45)", "package_ndc": "71610-435-45", "marketing_start_date": "20200616"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-435-53)", "package_ndc": "71610-435-53", "marketing_start_date": "20200616"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-435-60)", "package_ndc": "71610-435-60", "marketing_start_date": "20200630"}, {"sample": false, "description": "135 TABLET, FILM COATED in 1 BOTTLE (71610-435-73)", "package_ndc": "71610-435-73", "marketing_start_date": "20200616"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-435-80)", "package_ndc": "71610-435-80", "marketing_start_date": "20200616"}], "brand_name": "Sertraline Hydrochloride", "product_id": "71610-435_730d7b7d-3846-47b2-b527-c2bb233f8052", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71610-435", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Aphena Pharma Solutions - 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": "20070206", "listing_expiration_date": "20261231"}