thioridazine hydrochloride

Generic: thioridazine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name thioridazine hydrochloride
Generic Name thioridazine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

thioridazine hydrochloride 100 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 53489-500
Product ID 53489-500_2c96c6f9-3008-48ba-86ea-e9b83502da67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089953
Listing Expiration 2026-12-31
Marketing Start 1988-10-07

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53489500
Hyphenated Format 53489-500

Supplemental Identifiers

RxCUI
198270 198274 198275 313354
UNII
4WCI67NK8M

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 thioridazine hydrochloride (source: ndc)
Generic Name thioridazine hydrochloride (source: ndc)
Application Number ANDA089953 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-01)
  • 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-02)
  • 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-10)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-60)
source: ndc

Packages (7)

53489-500-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-01) 53489-500-02 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-02) 53489-500-03 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-03) 53489-500-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-05) 53489-500-06 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-06) 53489-500-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-10) 53489-500-60 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-60)

Ingredients (1)

thioridazine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Thioridazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c96c6f9-3008-48ba-86ea-e9b83502da67", "openfda": {"unii": ["4WCI67NK8M"], "rxcui": ["198270", "198274", "198275", "313354"], "spl_set_id": ["9c4bedb4-2d59-4fcd-aad7-fce988cd96d8"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-01)", "package_ndc": "53489-500-01", "marketing_start_date": "19881007"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-02)", "package_ndc": "53489-500-02", "marketing_start_date": "19881007"}, {"sample": false, "description": "250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-03)", "package_ndc": "53489-500-03", "marketing_start_date": "19881007"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-05)", "package_ndc": "53489-500-05", "marketing_start_date": "19881007"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-06)", "package_ndc": "53489-500-06", "marketing_start_date": "19881007"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-10)", "package_ndc": "53489-500-10", "marketing_start_date": "19881007"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-60)", "package_ndc": "53489-500-60", "marketing_start_date": "19881007"}], "brand_name": "Thioridazine Hydrochloride", "product_id": "53489-500_2c96c6f9-3008-48ba-86ea-e9b83502da67", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "53489-500", "generic_name": "Thioridazine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Thioridazine Hydrochloride", "active_ingredients": [{"name": "THIORIDAZINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA089953", "marketing_category": "ANDA", "marketing_start_date": "19881007", "listing_expiration_date": "20261231"}