0006-4309 NDC - STERILE DILUENT ()

Drug Information

  • Product NDC: 0006-4309
  • Proprietary Name: STERILE DILUENT
  • Non Proprietary Name:
  • Active Ingredient(s): .7 mL/.7mL WATER
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Merck Sharp & Dohme LLC
Product Type:
FDA Application Number: BLA125123
Marketing Category: BLA
Start Marketing Date:5/25/2006
End Marketing Date:11/18/2020

Package Information

No. Package Code Package Description Billing Unit
10006-4309-0010 VIAL, SINGLE-DOSE in 1 CARTON (0006-4309-00) / .7 mL in 1 VIAL, SINGLE-DOSE (0006-4309-01)ML
20006-4309-0010 VIAL, SINGLE-DOSE in 1 CARTON (0006-4309-00) / .7 mL in 1 VIAL, SINGLE-DOSE (0006-4309-01)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0006-4309The 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 NAMESTERILE DILUENTThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/25/2006This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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 NUMBERBLA125123This 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 NAMEMerck Sharp & Dohme LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0006-4309The 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 NAMESTERILE DILUENTThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/25/2006This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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 NUMBERBLA125123This 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 NAMEMerck Sharp & Dohme LLCName 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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