Search Icon

0009-7224 NDC - ATGAM (EQUINE THYMOCYTE IMMUNE GLOBULIN)

Drug Information

Product NDC: 0009-7224

Proprietary Name: Atgam

Non Proprietary Name: EQUINE THYMOCYTE IMMUNE GLOBULIN

Active Ingredient(s):
  • 50 mg/mL EQUINE THYMOCYTE IMMUNE GLOBULIN


Administration Route(s): INTRAVENOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Antibody-Surface Protein Interactions [MoA];
  • Immunoglobulin G [EPC];
  • Immunoglobulins [CS];
  • Increased T Lymphocyte Destruction [PE];
  • Lymphocyte Function Alteration [PE]

Labeler Information

Labeler Name: Pharmacia & Upjohn Company LLC
Product Type: PLASMA DERIVATIVE
FDA Application Number: BLA103676
Marketing Category: BLA
Start Marketing Date:11/17/1981

Package Information

No. Package Code Package Description Billing Unit
10009-7224-025 AMPULE in 1 CARTON (0009-7224-02) > 5 mL in 1 AMPULE (0009-7224-01)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0009-7224The 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 NAMEPLASMA DERIVATIVEIndicates 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.
PROPRIETARY NAMEAtgamThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEEQUINE THYMOCYTE IMMUNE GLOBULINThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE11/17/1981This 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 NUMBERBLA103676This 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 NAMEPharmacia & Upjohn Company LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEEQUINE THYMOCYTE IMMUNE GLOBULINAn 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 STRENGTH50 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESAntibody-Surface Protein Interactions [MoA], Immunoglobulin G [EPC], Immunoglobulins [CS], Increased T Lymphocyte Destruction [PE], Lymphocyte Function Alteration [PE] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 10/28/2022