81033-033 NDC - AMINOCAPROIC ACID

Drug Information

  • Product NDC: 81033-033
  • Proprietary Name: Aminocaproic acid
  • Non Proprietary Name: Aminocaproic acid
  • Active Ingredient(s): 500 mg/1 AMINOCAPROIC ACID
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Antifibrinolytic Agent [EPC]; Decreased Fibrinolysis [PE]

Labeler Information

Field Name Field Value
Labeler Name: Kesin Pharma Corporation
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA212938
Marketing Category: ANDA
Start Marketing Date:12/10/2020

Package Information

No. Package Code Package Description Billing Unit
181033-033-313 BLISTER PACK in 1 CARTON (81033-033-31) / 30 TABLET in 1 BLISTER PACK (81033-033-51)

NDC Record

Field Name Field Value Definition
PRODUCT NDC81033-033The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PROPRIETARY NAMEAminocaproic acidThe translation of the dosage form Code submitted by the firm.
NON PROPRIETARY NAMEAminocaproic acidThe translation of the route code submitted by the firm, indicating route of administration.
DOSAGE FORM NAMETABLETThis is the date that the labeler indicates was the start of its marketing of the drug product.
ROUTE NAMEORALProduct 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.
START MARKETING DATE12/10/2020This 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.
MARKETING CATEGORY NAMEANDAName of Company corresponding to the labeler code segment of the Product NDC.
APPLICATION NUMBERANDA212938An 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.
LABELER NAMEKesin Pharma Corporation 
SUBSTANCE NAMEAMINOCAPROIC ACID 
ACTIVE NUMERATOR STRENGTH500 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESAntifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE] 

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This page was last updated on: 11/7/2026

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