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 71610-651
Product ID 71610-651_a189f92d-a14a-45be-8f55-4b81fe2dce92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202825
Listing Expiration 2026-12-31
Marketing Start 2017-02-09

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 71610651
Hyphenated Format 71610-651

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 ANDA202825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-651-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-651-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-651-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-651-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-651-60)
  • 135 TABLET, FILM COATED in 1 BOTTLE (71610-651-73)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-651-80)
source: ndc

Packages (7)

71610-651-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-651-15) 71610-651-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-651-30) 71610-651-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-651-45) 71610-651-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-651-53) 71610-651-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-651-60) 71610-651-73 135 TABLET, FILM COATED in 1 BOTTLE (71610-651-73) 71610-651-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-651-80)

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": "a189f92d-a14a-45be-8f55-4b81fe2dce92", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938"], "spl_set_id": ["68c94fb4-3018-44af-b982-2b4b6d461e6f"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-651-15)", "package_ndc": "71610-651-15", "marketing_start_date": "20220623"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-651-30)", "package_ndc": "71610-651-30", "marketing_start_date": "20220620"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-651-45)", "package_ndc": "71610-651-45", "marketing_start_date": "20220620"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-651-53)", "package_ndc": "71610-651-53", "marketing_start_date": "20220620"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-651-60)", "package_ndc": "71610-651-60", "marketing_start_date": "20220620"}, {"sample": false, "description": "135 TABLET, FILM COATED in 1 BOTTLE (71610-651-73)", "package_ndc": "71610-651-73", "marketing_start_date": "20220620"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-651-80)", "package_ndc": "71610-651-80", "marketing_start_date": "20220620"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "71610-651_a189f92d-a14a-45be-8f55-4b81fe2dce92", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71610-651", "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": "ANDA202825", "marketing_category": "ANDA", "marketing_start_date": "20170209", "listing_expiration_date": "20261231"}