FDA.reportPublic FDA data

Cytogam

Product NDC
49591-532
11-digit product format
495910532
Labeler code
49591
Product ID
49591-532_eaa03089-26d4-4945-b075-634cbf56dad2
Type
PLASMA DERIVATIVE
Nonproprietary name
HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN
Dosage form
LIQUID
Route
INTRAVENOUS
Labeler
Kamada Ltd.
Application
BLA103189
Marketing category
BLA
Marketing start
2023-06-01
Substance
HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN
Active strength
2500 mg/50mL
Pharmacologic classes
Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN2500 mg/50mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49591-532-50Cytogam50 mL in 1 VIAL, GLASSLIQUID501
49591-532-51Cytogam1 in 1 CARTONLIQUID11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49591-532-50ML - Milliliter49591-53261657e04-aef4-47c4-a78d-5bc1adb477ff12023-10-16
49591-532-51ML - Milliliter49591-53269e6de23-ea6c-4fc8-b15b-b10f673b06e112023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49591-532CYTOGAM (HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN) LIQUID [KAMADA LTD.]1Current NDC, 2 package rows20230602_c8e2bb3f-2a4d-4c55-b145-ba96c1928d44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209029Cytogam 2.5 GM in 50 ML InjectionPSNc8e2bb3f-2a4d-4c55-b145-ba96c1928d441
204528cytomegalovirus immune globulin, human 2.5 GM in 50 mL InjectionPSNc8e2bb3f-2a4d-4c55-b145-ba96c1928d441
20902950 ML cytomegalovirus immune globulin, human 50 MG/ML Injection [Cytogam]SBDc8e2bb3f-2a4d-4c55-b145-ba96c1928d441
20452850 ML cytomegalovirus immune globulin, human 50 MG/ML InjectionSCDc8e2bb3f-2a4d-4c55-b145-ba96c1928d441
20902950 ML Cytogam 50 MG/ML InjectionSYc8e2bb3f-2a4d-4c55-b145-ba96c1928d441
209029Cytogam 2.5 GM per 50 ML InjectionSYc8e2bb3f-2a4d-4c55-b145-ba96c1928d441
209029Cytogam 2500 MG per 50 ML InjectionSYc8e2bb3f-2a4d-4c55-b145-ba96c1928d441
204528cytomegalovirus immune globulin, human 2.5 GM per 50 ML InjectionSYc8e2bb3f-2a4d-4c55-b145-ba96c1928d441
204528cytomegalovirus immune globulin, human 2500 MG per 50 ML InjectionSYc8e2bb3f-2a4d-4c55-b145-ba96c1928d441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49591-532-504959105325050 mL in 1 VIAL, GLASS50 mlHistorical
49591-532-51495910532511 VIAL, GLASS in 1 CARTON (49591-532-51) / 50 mL in 1 VIAL, GLASS (49591-532-50) 2023-06-01NoNoHistorical