Atgam

Product NDC
0009-7224
11-digit product format
000097224
Labeler code
0009
Product ID
0009-7224_a96a4454-b33e-409c-b58c-af3144b36dea
Type
PLASMA DERIVATIVE
Nonproprietary name
EQUINE THYMOCYTE IMMUNE GLOBULIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
BLA103676
Marketing category
BLA
Marketing start
1981-11-17
Substance
EQUINE THYMOCYTE IMMUNE GLOBULIN
Active strength
50 mg/mL
Pharmacologic classes
Antibody-Surface Protein Interactions [MoA], Immunoglobulin G [EPC], Immunoglobulins [CS], Increased T Lymphocyte Destruction [PE], Lymphocyte Function Alteration [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atgam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EQUINE THYMOCYTE IMMUNE GLOBULIN50 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-7224-01Atgam5 mL in 1 AMPULEINJECTION, SOLUTION521
0009-7224-02Atgam5 in 1 CARTONINJECTION, SOLUTION521

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-7224-01ML - Milliliter0009-7224a1e0d1c5-a772-44a7-a147-18e9d5cf408d12013-12-02
0009-7224-02ML - Milliliter0009-7224d28c5a24-d6e3-4626-bcb7-de9d150e12a012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EQUINE THYMOCYTE IMMUNE GLOBULINACTIVE INGREDIENT475247QF1ZATGAM (EQUINE THYMOCYTE IMMUNE GLOBULIN) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]9
EQUINE THYMOCYTE IMMUNE GLOBULINACTIVE MOIETY475247QF1ZATGAM (EQUINE THYMOCYTE IMMUNE GLOBULIN) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-7224ATGAM (EQUINE THYMOCYTE IMMUNE GLOBULIN) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]21Current NDC, Legacy NDC, 2 package rows20240620_bd545ba1-2366-4df1-bd67-10dfd7632b54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206289Atgam 250 MG in 5 ML InjectionPSNbd545ba1-2366-4df1-bd67-10dfd7632b5421
197906lymphocyte immune globulin, anti-thymocyte, equine 250 MG in 5 mL InjectionPSNbd545ba1-2366-4df1-bd67-10dfd7632b5421
2062895 ML lymphocyte immune globulin, anti-thymocyte globulin, equine 50 MG/ML Injection [ATGAM]SBDbd545ba1-2366-4df1-bd67-10dfd7632b5421
1979065 ML lymphocyte immune globulin, anti-thymocyte globulin, equine 50 MG/ML InjectionSCDbd545ba1-2366-4df1-bd67-10dfd7632b5421
2062895 ML ATGAM 50 MG/ML InjectionSYbd545ba1-2366-4df1-bd67-10dfd7632b5421
206289Atgam 250 MG per 5 ML InjectionSYbd545ba1-2366-4df1-bd67-10dfd7632b5421
197906lymphocyte immune globulin, anti-thymocyte, equine 250 MG per 5 ML InjectionSYbd545ba1-2366-4df1-bd67-10dfd7632b5421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-7224-01000097224015 mL in 1 AMPULE5 mlHistorical
0009-7224-02000097224025 AMPULE in 1 CARTON (0009-7224-02) / 5 mL in 1 AMPULE (0009-7224-01) 5 ampule1981-11-170000-00-00NoNoCurrent