sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC 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 71610-433
Product ID 71610-433_7c2f1809-97f9-4942-a4f0-5fe016dd709a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019839
Listing Expiration 2026-12-31
Marketing Start 2019-08-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610433
Hyphenated Format 71610-433

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 NDA019839 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-433-15)
source: ndc

Packages (1)

71610-433-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-433-15)

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": "7c2f1809-97f9-4942-a4f0-5fe016dd709a", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938"], "spl_set_id": ["ccb264a4-5d50-4317-a67e-ba6daa2b8297"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-433-15)", "package_ndc": "71610-433-15", "marketing_start_date": "20200616"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "71610-433_7c2f1809-97f9-4942-a4f0-5fe016dd709a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71610-433", "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": "NDA019839", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190812", "listing_expiration_date": "20261231"}