sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-013
Product ID 72789-013_2b9a4ac0-8999-2dfc-e063-6394a90a70e1
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 72789013
Hyphenated Format 72789-013

Supplemental Identifiers

RxCUI
312941
UPC
0372789013909
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
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-90)
source: ndc

Packages (3)

72789-013-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-30) 72789-013-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-60) 72789-013-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-90)

Ingredients (1)

sertraline hydrochloride (50 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": "2b9a4ac0-8999-2dfc-e063-6394a90a70e1", "openfda": {"upc": ["0372789013909"], "unii": ["UTI8907Y6X"], "rxcui": ["312941"], "spl_set_id": ["ae3be25b-2bde-4142-ad56-920a96ac8f39"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-30)", "package_ndc": "72789-013-30", "marketing_start_date": "20190924"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-60)", "package_ndc": "72789-013-60", "marketing_start_date": "20201106"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-90)", "package_ndc": "72789-013-90", "marketing_start_date": "20190924"}], "brand_name": "Sertraline Hydrochloride", "product_id": "72789-013_2b9a4ac0-8999-2dfc-e063-6394a90a70e1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72789-013", "generic_name": "Sertraline Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA077206", "marketing_category": "ANDA", "marketing_start_date": "20070206", "listing_expiration_date": "20261231"}