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 43353-447
Product ID 43353-447_2fb33cad-68d5-7110-e063-6394a90ab175
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077206
Listing Expiration 2026-12-31
Marketing Start 2007-02-06

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 43353447
Hyphenated Format 43353-447

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
  • 15 TABLET, FILM COATED in 1 BOTTLE (43353-447-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (43353-447-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (43353-447-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (43353-447-53)
  • 135 TABLET, FILM COATED in 1 BOTTLE (43353-447-73)
source: ndc

Packages (5)

43353-447-15 15 TABLET, FILM COATED in 1 BOTTLE (43353-447-15) 43353-447-30 30 TABLET, FILM COATED in 1 BOTTLE (43353-447-30) 43353-447-45 45 TABLET, FILM COATED in 1 BOTTLE (43353-447-45) 43353-447-53 60 TABLET, FILM COATED in 1 BOTTLE (43353-447-53) 43353-447-73 135 TABLET, FILM COATED in 1 BOTTLE (43353-447-73)

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": "2fb33cad-68d5-7110-e063-6394a90ab175", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938"], "spl_set_id": ["680890b1-bc45-4f50-9aaf-e730ab515b85"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (43353-447-15)", "package_ndc": "43353-447-15", "marketing_start_date": "20180731"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43353-447-30)", "package_ndc": "43353-447-30", "marketing_start_date": "20180731"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (43353-447-45)", "package_ndc": "43353-447-45", "marketing_start_date": "20180731"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (43353-447-53)", "package_ndc": "43353-447-53", "marketing_start_date": "20180731"}, {"sample": false, "description": "135 TABLET, FILM COATED in 1 BOTTLE (43353-447-73)", "package_ndc": "43353-447-73", "marketing_start_date": "20250305"}], "brand_name": "Sertraline Hydrochloride", "product_id": "43353-447_2fb33cad-68d5-7110-e063-6394a90ab175", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43353-447", "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"}