65044-2161 NDC - BACILLUS ANTHRACIS

Drug Information

Product NDC: 65044-2161

Proprietary Name:

Non Proprietary Name: bacillus anthracis

Active Ingredient(s):
  • 100 ug/mL BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS


Administration Route(s):

Dosage Form(s): INJECTION, SUSPENSION

Labeler Information

Labeler Name: Jubilant HollisterStier LLC
Product Type: LICENSED VACCINE BULK INTERMEDIATE
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:1/31/2002

Package Information

No. Package Code Package Description Billing Unit
165044-2161-15 mL in 1 VIAL, MULTI-DOSE (65044-2161-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC65044-2161The 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.
PRODUCT TYPE NAMELICENSED VACCINE BULK INTERMEDIATEIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
NON PROPRIETARY NAMEbacillus anthracisThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SUSPENSIONThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE1/31/2002This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGProduct 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.
LABELER NAMEJubilant HollisterStier LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENSAn 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 STRENGTH100 
ACTIVE INGRED UNITug/mL 

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This page was last updated on: 5/3/2024