torsemide

Generic: torsemide

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name torsemide
Generic Name torsemide
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

torsemide 20 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0077
Product ID 0054-0077_978f435d-eae6-49b7-80cd-6c951abce99f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076943
Listing Expiration 2026-12-31
Marketing Start 2005-03-03

Pharmacologic Class

Established (EPC)
loop diuretic [epc]
Physiologic Effect
increased diuresis at loop of henle [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540077
Hyphenated Format 0054-0077

Supplemental Identifiers

RxCUI
198371
UNII
W31X2H97FB
NUI
N0000175366 N0000175590

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 torsemide (source: ndc)
Generic Name torsemide (source: ndc)
Application Number ANDA076943 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0054-0077-25)
  • 500 TABLET in 1 BOTTLE, PLASTIC (0054-0077-29)
source: ndc

Packages (2)

0054-0077-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-0077-25) 0054-0077-29 500 TABLET in 1 BOTTLE, PLASTIC (0054-0077-29)

Ingredients (1)

torsemide (20 mg/1)

Linked Drug Pages (1)

Torsemide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "978f435d-eae6-49b7-80cd-6c951abce99f", "openfda": {"nui": ["N0000175366", "N0000175590"], "unii": ["W31X2H97FB"], "rxcui": ["198371"], "spl_set_id": ["fde1d1be-0faa-440a-9039-bdb103288c76"], "pharm_class_pe": ["Increased Diuresis at Loop of Henle [PE]"], "pharm_class_epc": ["Loop Diuretic [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0054-0077-25)", "package_ndc": "0054-0077-25", "marketing_start_date": "20050303"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (0054-0077-29)", "package_ndc": "0054-0077-29", "marketing_start_date": "20050303"}], "brand_name": "Torsemide", "product_id": "0054-0077_978f435d-eae6-49b7-80cd-6c951abce99f", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis at Loop of Henle [PE]", "Loop Diuretic [EPC]"], "product_ndc": "0054-0077", "generic_name": "Torsemide", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Torsemide", "active_ingredients": [{"name": "TORSEMIDE", "strength": "20 mg/1"}], "application_number": "ANDA076943", "marketing_category": "ANDA", "marketing_start_date": "20050303", "listing_expiration_date": "20261231"}