FDA.reportPublic FDA data

Flebogamma

Product NDC
61953-0004
11-digit product format
619530004
Labeler code
61953
Product ID
61953-0004_6c2e3e83-43fe-48d2-b6a6-7b78870210b7
Type
PLASMA DERIVATIVE
Nonproprietary name
Immune Globulin (Human)
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
GRIFOLS USA, LLC
Application
BLA125077
Marketing category
BLA
Marketing start
2006-12-21
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
.05 g/mL
Pharmacologic classes
Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flebogamma
Brand name suffix
DIF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G.05 g/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61953-0004-0FlebogammaDIF400 mL in 1 VIALINJECTION, SOLUTION40034
61953-0004-3FlebogammaDIF1 in 1 CARTONINJECTION, SOLUTION134
61953-0004-4FlebogammaDIF1 in 1 CARTONINJECTION, SOLUTION134
61953-0004-5FlebogammaDIF1 in 1 CARTONINJECTION, SOLUTION134
61953-0004-8FlebogammaDIF100 mL in 1 VIALINJECTION, SOLUTION10034
61953-0004-9FlebogammaDIF200 mL in 1 VIALINJECTION, SOLUTION20034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61953-0004-0ML - Milliliter61953-0004e7d827df-790e-49a6-9670-4d510fe6233212014-01-04
61953-0004-1ML - Milliliter61953-00044377b6f1-b815-46ba-959f-ee38e7784e4812012-07-24
61953-0004-2ML - Milliliter61953-000425854a6b-6728-4ae8-82b0-0f4a45c8f05312012-07-24
61953-0004-3ML - Milliliter61953-00040b15af78-2939-4758-8bb8-8bb9297b580512012-07-24
61953-0004-4ML - Milliliter61953-00049caa851d-bb3e-4c66-a5a3-1a894f79a12312012-07-24
61953-0004-5ML - Milliliter61953-000411b88aef-4aff-4026-9a8a-04e28f9a8fa912012-07-24
61953-0004-6ML - Milliliter61953-0004fb5d691d-fd7f-4759-b6ce-86d6af731cce12014-01-04
61953-0004-7ML - Milliliter61953-0004cfcd789c-7b32-4725-a298-d2276d1c055012014-01-04
61953-0004-8ML - Milliliter61953-0004fe5a8b94-fccb-42c0-8263-dcb6f4ab1fb212014-01-04
61953-0004-9ML - Milliliter61953-00049bf65b21-37eb-4906-b5b1-b9d2180c00f312014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN IMMUNOGLOBULIN GACTIVE INGREDIENT66Y330CJHSFLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]13
HUMAN IMMUNOGLOBULIN GACTIVE MOIETY66Y330CJHSFLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]13
SORBITOLINACTIVE INGREDIENT506T60A25RFLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]13
WATERINACTIVE INGREDIENT059QF0KO0RFLEBOGAMMA DIF (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [GRIFOLS USA, LLC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61953-0004FLEBOGAMMA DIF (IMMUNE GLOBULIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]33Current NDC, Legacy NDC, 6 package rows20241204_2cf22c72-64ac-45be-b7c6-d20340730096.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809457Flebogamma 5 % in 100 ML InjectionPSN2cf22c72-64ac-45be-b7c6-d2034073009634
1809464Flebogamma 5 % in 200 ML InjectionPSN2cf22c72-64ac-45be-b7c6-d2034073009634
1809475Flebogamma 5 % in 400 ML InjectionPSN2cf22c72-64ac-45be-b7c6-d2034073009634
1809456immunoglobulin G, human 5 % in 100 ML InjectionPSN2cf22c72-64ac-45be-b7c6-d2034073009634
1809463immunoglobulin G, human 5 % in 200 ML InjectionPSN2cf22c72-64ac-45be-b7c6-d2034073009634
1809474immunoglobulin G, human 5 % in 400 ML InjectionPSN2cf22c72-64ac-45be-b7c6-d2034073009634
1809457100 ML immunoglobulin G, human 50 MG/ML Injection [Flebogamma]SBD2cf22c72-64ac-45be-b7c6-d2034073009634
1809464200 ML immunoglobulin G, human 50 MG/ML Injection [Flebogamma]SBD2cf22c72-64ac-45be-b7c6-d2034073009634
1809475400 ML immunoglobulin G, human 50 MG/ML Injection [Flebogamma]SBD2cf22c72-64ac-45be-b7c6-d2034073009634
1809456100 ML immunoglobulin G, human 50 MG/ML InjectionSCD2cf22c72-64ac-45be-b7c6-d2034073009634
1809463200 ML immunoglobulin G, human 50 MG/ML InjectionSCD2cf22c72-64ac-45be-b7c6-d2034073009634
1809474400 ML immunoglobulin G, human 50 MG/ML InjectionSCD2cf22c72-64ac-45be-b7c6-d2034073009634
1809457100 ML Flebogamma 50 MG/ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809464200 ML Flebogamma 50 MG/ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809475400 ML Flebogamma 50 MG/ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809464Flebogamma 10 GM per 200 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809475Flebogamma 20 GM per 400 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809457Flebogamma 5 % per 100 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809464Flebogamma 5 % per 200 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809475Flebogamma 5 % per 400 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809457Flebogamma 5 GM per 100 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809463immunoglobulin G, human 10 GM per 200 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809474immunoglobulin G, human 20 GM per 400 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809456immunoglobulin G, human 5 % per 100 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809463immunoglobulin G, human 5 % per 200 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809474immunoglobulin G, human 5 % per 400 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634
1809456immunoglobulin G, human 5 GM per 100 ML InjectionSY2cf22c72-64ac-45be-b7c6-d2034073009634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61953-0004-061953000400400 mL in 1 VIAL400 mlHistorical
61953-0004-1619530004011 VIAL in 1 CARTON (61953-0004-1) > 10 mL in 1 VIAL (61953-0004-6) 1 vial2006-12-210000-00-00NoNoCurrent
61953-0004-2619530004021 VIAL in 1 CARTON (61953-0004-2) > 50 mL in 1 VIAL (61953-0004-7) 1 vial2006-12-210000-00-00NoNoCurrent
61953-0004-3619530004031 VIAL in 1 CARTON (61953-0004-3) / 100 mL in 1 VIAL (61953-0004-8) 1 vial2006-12-210000-00-00NoNoCurrent
61953-0004-4619530004041 VIAL in 1 CARTON (61953-0004-4) / 200 mL in 1 VIAL (61953-0004-9) 1 vial2006-12-210000-00-00NoNoCurrent
61953-0004-5619530004051 VIAL in 1 CARTON (61953-0004-5) / 400 mL in 1 VIAL (61953-0004-0) 1 vial2006-12-210000-00-00NoNoCurrent
61953-0004-861953000408100 mL in 1 VIAL100 mlHistorical
61953-0004-961953000409200 mL in 1 VIAL200 mlHistorical