70756-081 NDC - BUMETANIDE

Drug Information

  • Product NDC: 70756-081
  • Proprietary Name: Bumetanide
  • Non Proprietary Name: Bumetanide
  • Active Ingredient(s): 2 mg/1 BUMETANIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Increased Diuresis at Loop of Henle [PE]; Loop Diuretic [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Lifestar Pharma LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA219291
Marketing Category: ANDA
Start Marketing Date:4/3/2025

Package Information

No. Package Code Package Description Billing Unit
170756-081-11100 TABLET in 1 BOTTLE (70756-081-11)EA
270756-081-51500 TABLET in 1 BOTTLE (70756-081-51)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC70756-081This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGName of Company corresponding to the labeler code segment of the Product NDC.
PROPRIETARY NAMEBumetanideAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
NON PROPRIETARY NAMEBumetanide 
DOSAGE FORM NAMETABLET 
ROUTE NAMEORAL 
START MARKETING DATE4/3/2025This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA219291This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMELifestar Pharma LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBUMETANIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH2 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESIncreased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC] 

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This page was last updated on: 12/6/2025

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