FDA.reportPublic FDA data

Octagam Immune Globulin (Human)

Product NDC
68982-840
11-digit product format
689820840
Labeler code
68982
Product ID
68982-840_1ceaed06-d43c-a23d-a4e0-dce0de4ad7f0
Type
PLASMA DERIVATIVE
Nonproprietary name
Immune Globulin
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Octapharma USA Inc
Application
BLA125062
Marketing category
BLA
Marketing start
2004-05-21
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
50 mg/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
Octagam Immune Globulin (Human)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G50 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68982-840-01Octagam Immune Globulin (Human)20 mL in 1 BOTTLE, GLASSSOLUTION2011
68982-840-02Octagam Immune Globulin (Human)50 mL in 1 BOTTLE, GLASSSOLUTION5011
68982-840-03Octagam Immune Globulin (Human)100 mL in 1 BOTTLE, GLASSSOLUTION10011
68982-840-04Octagam Immune Globulin (Human)200 mL in 1 BOTTLE, GLASSSOLUTION20011
68982-840-05Octagam Immune Globulin (Human)500 mL in 1 BOTTLE, GLASSSOLUTION50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68982-840-01ML - Milliliter68982-840f4ea7415-ed0a-4fe8-ba14-d4349a7f0f4c12015-11-12
68982-840-02ML - Milliliter68982-84083d3e5d8-9ad0-4e4e-aa72-86369a1f035612015-11-12
68982-840-03ML - Milliliter68982-84037e8a8c7-032d-4025-b187-72aa6b1a69e912015-11-12
68982-840-04ML - Milliliter68982-840799f898c-ce25-47ee-8287-c3d2f823bc2c12015-11-12
68982-840-05ML - Milliliter68982-84071660a9c-fca8-45b3-9145-cf22b181801112015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN IMMUNOGLOBULIN GACTIVE INGREDIENT66Y330CJHSOCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [OCTAPHARMA USA INC]2
HUMAN IMMUNOGLOBULIN GACTIVE MOIETY66Y330CJHSOCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [OCTAPHARMA USA INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-840OCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [OCTAPHARMA USA INC]11Current NDC, Legacy NDC, 5 package rows20221115_de00abeb-d635-eddc-b603-10708ecef5aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809456immunoglobulin G, human 5 % in 100 ML InjectionPSNde00abeb-d635-eddc-b603-10708ecef5aa11
1809642immunoglobulin G, human 5 % in 20 ML InjectionPSNde00abeb-d635-eddc-b603-10708ecef5aa11
1809463immunoglobulin G, human 5 % in 200 ML InjectionPSNde00abeb-d635-eddc-b603-10708ecef5aa11
1809447immunoglobulin G, human 5 % in 50 ML InjectionPSNde00abeb-d635-eddc-b603-10708ecef5aa11
1809651immunoglobulin G, human 5 % in 500 ML InjectionPSNde00abeb-d635-eddc-b603-10708ecef5aa11
1809648octagam 5 % in 100 ML InjectionPSNde00abeb-d635-eddc-b603-10708ecef5aa11
1809643octagam 5 % in 20 ML InjectionPSNde00abeb-d635-eddc-b603-10708ecef5aa11
1809649octagam 5 % in 200 ML InjectionPSNde00abeb-d635-eddc-b603-10708ecef5aa11
1809647octagam 5 % in 50 ML InjectionPSNde00abeb-d635-eddc-b603-10708ecef5aa11
1809652octagam 5 % in 500 ML InjectionPSNde00abeb-d635-eddc-b603-10708ecef5aa11
1809648100 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBDde00abeb-d635-eddc-b603-10708ecef5aa11
180964320 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBDde00abeb-d635-eddc-b603-10708ecef5aa11
1809649200 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBDde00abeb-d635-eddc-b603-10708ecef5aa11
180964750 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBDde00abeb-d635-eddc-b603-10708ecef5aa11
1809652500 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBDde00abeb-d635-eddc-b603-10708ecef5aa11
1809456100 ML immunoglobulin G, human 50 MG/ML InjectionSCDde00abeb-d635-eddc-b603-10708ecef5aa11
180964220 ML immunoglobulin G, human 50 MG/ML InjectionSCDde00abeb-d635-eddc-b603-10708ecef5aa11
1809463200 ML immunoglobulin G, human 50 MG/ML InjectionSCDde00abeb-d635-eddc-b603-10708ecef5aa11
180944750 ML immunoglobulin G, human 50 MG/ML InjectionSCDde00abeb-d635-eddc-b603-10708ecef5aa11
1809651500 ML immunoglobulin G, human 50 MG/ML InjectionSCDde00abeb-d635-eddc-b603-10708ecef5aa11
1809648100 ML Octagam 50 MG/ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
180964320 ML Octagam 50 MG/ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809649200 ML Octagam 50 MG/ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
180964750 ML Octagam 50 MG/ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809652500 ML Octagam 50 MG/ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809642immunoglobulin G, human 1 GM per 20 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809463immunoglobulin G, human 10 GM per 200 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809447immunoglobulin G, human 2.5 GM per 50 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809651immunoglobulin G, human 25 GM per 500 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809456immunoglobulin G, human 5 % per 100 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809642immunoglobulin G, human 5 % per 20 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809463immunoglobulin G, human 5 % per 200 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809447immunoglobulin G, human 5 % per 50 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809651immunoglobulin G, human 5 % per 500 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809456immunoglobulin G, human 5 GM per 100 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809643Octagam 1 GM per 20 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809649Octagam 10 GM per 200 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809647Octagam 2.5 GM per 50 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809652Octagam 25 GM per 500 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809648Octagam 5 % per 100 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809643Octagam 5 % per 20 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809649Octagam 5 % per 200 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809647Octagam 5 % per 50 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809652Octagam 5 % per 500 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11
1809648Octagam 5 GM per 100 ML InjectionSYde00abeb-d635-eddc-b603-10708ecef5aa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68982-840-016898208400120 mL in 1 BOTTLE, GLASS (68982-840-01) 20 ml2004-05-210000-00-00NoNoCurrent
68982-840-026898208400250 mL in 1 BOTTLE, GLASS (68982-840-02) 50 ml2004-05-210000-00-00NoNoCurrent
68982-840-0368982084003100 mL in 1 BOTTLE, GLASS (68982-840-03) 100 ml2004-05-210000-00-00NoNoCurrent
68982-840-0468982084004200 mL in 1 BOTTLE, GLASS (68982-840-04) 200 ml2004-05-210000-00-00NoNoCurrent
68982-840-0568982084005500 mL in 1 BOTTLE, GLASS (68982-840-05) 500 ml2004-05-210000-00-00NoNoCurrent