sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: xlcare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler xlcare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sertraline hydrochloride 25 mg/1

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-205
Product ID 72865-205_918e3fe6-8b38-4ec8-accb-09b2d82ff404
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214790
Listing Expiration 2026-12-31
Marketing Start 2021-05-03

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 72865205
Hyphenated Format 72865-205

Supplemental Identifiers

RxCUI
312938 312940 312941
UPC
0372865205303 0372865205907 0372865207307 0372865206904 0372865205181 0372865205051 0372865206188 0372865207901 0372865206058 0372865206300 0372865207055 0372865207185
UNII
UTI8907Y6X

Packaging Origin

Original Packager
true

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 ANDA214790 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (72865-205-05)
  • 180 TABLET in 1 BOTTLE (72865-205-18)
  • 30 TABLET in 1 BOTTLE (72865-205-30)
  • 90 TABLET in 1 BOTTLE (72865-205-90)
source: ndc

Packages (4)

72865-205-05 500 TABLET in 1 BOTTLE (72865-205-05) 72865-205-18 180 TABLET in 1 BOTTLE (72865-205-18) 72865-205-30 30 TABLET in 1 BOTTLE (72865-205-30) 72865-205-90 90 TABLET in 1 BOTTLE (72865-205-90)

Ingredients (1)

sertraline hydrochloride (25 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": "918e3fe6-8b38-4ec8-accb-09b2d82ff404", "openfda": {"upc": ["0372865205303", "0372865205907", "0372865207307", "0372865206904", "0372865205181", "0372865205051", "0372865206188", "0372865207901", "0372865206058", "0372865206300", "0372865207055", "0372865207185"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["5b73a90e-b883-419b-b30f-a379eed764d9"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (72865-205-05)", "package_ndc": "72865-205-05", "marketing_start_date": "20210503"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (72865-205-18)", "package_ndc": "72865-205-18", "marketing_start_date": "20210503"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72865-205-30)", "package_ndc": "72865-205-30", "marketing_start_date": "20210503"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72865-205-90)", "package_ndc": "72865-205-90", "marketing_start_date": "20210503"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "72865-205_918e3fe6-8b38-4ec8-accb-09b2d82ff404", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72865-205", "generic_name": "sertraline hydrochloride", "labeler_name": "XLCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SERTRALINE HYDROCHLORIDE", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA214790", "marketing_category": "ANDA", "marketing_start_date": "20210503", "listing_expiration_date": "20261231"}