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 100 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-273
Product ID 72789-273_40bac53e-393d-b295-e063-6294a90a5b88
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 72789273
Hyphenated Format 72789-273

Supplemental Identifiers

RxCUI
312938
UPC
0372789273013
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
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-273-01)
source: ndc

Packages (1)

72789-273-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-273-01)

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": "40bac53e-393d-b295-e063-6294a90a5b88", "openfda": {"upc": ["0372789273013"], "unii": ["UTI8907Y6X"], "rxcui": ["312938"], "spl_set_id": ["3ca30f3f-545e-46c5-b56a-73ec48e9647f"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-273-01)", "package_ndc": "72789-273-01", "marketing_start_date": "20220920"}], "brand_name": "Sertraline Hydrochloride", "product_id": "72789-273_40bac53e-393d-b295-e063-6294a90a5b88", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72789-273", "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": "100 mg/1"}], "application_number": "ANDA077206", "marketing_category": "ANDA", "marketing_start_date": "20070206", "listing_expiration_date": "20261231"}