0409-4346 NDC - AMINOCAPROIC ACID ()

Drug Information

  • Product NDC: 0409-4346
  • Proprietary Name: AMINOCAPROIC ACID
  • Non Proprietary Name:
  • Active Ingredient(s): 250 mg/mL AMINOCAPROIC ACID
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Antifibrinolytic Agent [EPC]; Decreased Fibrinolysis [PE]

Labeler Information

Field Name Field Value
Labeler Name: Hospira, Inc.
Product Type:
FDA Application Number: ANDA070010
Marketing Category: ANDA
Start Marketing Date:11/4/2014
End Marketing Date:3/1/2020

Package Information

No. Package Code Package Description Billing Unit
10409-4346-1025 VIAL, SINGLE-DOSE in 1 CARTON (0409-4346-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-4346-09)ML
20409-4346-7325 VIAL, SINGLE-DOSE in 1 TRAY (0409-4346-73) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-4346-16)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0409-4346The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEAMINOCAPROIC ACIDThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE11/4/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NUMBERANDA070010This 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 NAMEHospira, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0409-4346The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEAminocaproic AcidThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/12/2010This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NUMBERANDA070010This 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 NAMEHospira, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025

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