sertraline hcl

Generic: sertraline hcl

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hcl
Generic Name sertraline hcl
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-551
Product ID 72189-551_1894b61a-705c-a0c2-e063-6394a90afdba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077206
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

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 72189551
Hyphenated Format 72189-551

Supplemental Identifiers

RxCUI
312941
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 hcl (source: ndc)
Generic Name sertraline hcl (source: ndc)
Application Number ANDA077206 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-551-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-551-90)
source: ndc

Packages (2)

72189-551-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-551-30) 72189-551-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-551-90)

Ingredients (1)

sertraline hydrochloride (50 mg/1)

Linked Drug Pages (1)

Sertraline HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1894b61a-705c-a0c2-e063-6394a90afdba", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312941"], "spl_set_id": ["1766ea8b-bb88-8bb8-e063-6394a90a032d"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-551-30)", "package_ndc": "72189-551-30", "marketing_start_date": "20240501"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-551-90)", "package_ndc": "72189-551-90", "marketing_start_date": "20240501"}], "brand_name": "Sertraline HCL", "product_id": "72189-551_1894b61a-705c-a0c2-e063-6394a90afdba", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72189-551", "generic_name": "Sertraline HCL", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline HCL", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA077206", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}