FDA.reportPublic FDA data

Octagam Immune Globulin (Human)

Product NDC
0069-8400
11-digit product format
000698400
Labeler code
0069
Product ID
0069-8400_a08c35a4-9c25-5ceb-f3c4-0901519057b9
Type
PLASMA DERIVATIVE
Nonproprietary name
Immune Globulin
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA125062
Marketing category
BLA
Marketing start
2023-11-13
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
0069-8400-01Octagam Immune Globulin (Human)20 mL in 1 BOTTLE, GLASSSOLUTION203
0069-8400-02Octagam Immune Globulin (Human)1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-8400-01ML - Milliliter0069-8400946911ed-d466-4fcf-8ac1-6f1015e55d5712023-12-05
0069-8400-02ML - Milliliter0069-84008914e790-b6b0-464e-81c4-96d055e40d8812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-8400OCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]3Current NDC, 2 package rows20240130_fb07257b-e5e2-64c8-666c-65009f0aa604.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809456immunoglobulin G, human 5 % in 100 ML InjectionPSNfb07257b-e5e2-64c8-666c-65009f0aa6043
1809642immunoglobulin G, human 5 % in 20 ML InjectionPSNfb07257b-e5e2-64c8-666c-65009f0aa6043
1809463immunoglobulin G, human 5 % in 200 ML InjectionPSNfb07257b-e5e2-64c8-666c-65009f0aa6043
1809447immunoglobulin G, human 5 % in 50 ML InjectionPSNfb07257b-e5e2-64c8-666c-65009f0aa6043
1809648octagam 5 % in 100 ML InjectionPSNfb07257b-e5e2-64c8-666c-65009f0aa6043
1809643octagam 5 % in 20 ML InjectionPSNfb07257b-e5e2-64c8-666c-65009f0aa6043
1809649octagam 5 % in 200 ML InjectionPSNfb07257b-e5e2-64c8-666c-65009f0aa6043
1809647octagam 5 % in 50 ML InjectionPSNfb07257b-e5e2-64c8-666c-65009f0aa6043
1809648100 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBDfb07257b-e5e2-64c8-666c-65009f0aa6043
180964320 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBDfb07257b-e5e2-64c8-666c-65009f0aa6043
1809649200 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBDfb07257b-e5e2-64c8-666c-65009f0aa6043
180964750 ML immunoglobulin G, human 50 MG/ML Injection [Octagam]SBDfb07257b-e5e2-64c8-666c-65009f0aa6043
1809456100 ML immunoglobulin G, human 50 MG/ML InjectionSCDfb07257b-e5e2-64c8-666c-65009f0aa6043
180964220 ML immunoglobulin G, human 50 MG/ML InjectionSCDfb07257b-e5e2-64c8-666c-65009f0aa6043
1809463200 ML immunoglobulin G, human 50 MG/ML InjectionSCDfb07257b-e5e2-64c8-666c-65009f0aa6043
180944750 ML immunoglobulin G, human 50 MG/ML InjectionSCDfb07257b-e5e2-64c8-666c-65009f0aa6043
1809648100 ML Octagam 50 MG/ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
180964320 ML Octagam 50 MG/ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809649200 ML Octagam 50 MG/ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
180964750 ML Octagam 50 MG/ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809642immunoglobulin G, human 1 GM per 20 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809463immunoglobulin G, human 10 GM per 200 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809447immunoglobulin G, human 2.5 GM per 50 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809456immunoglobulin G, human 5 % per 100 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809642immunoglobulin G, human 5 % per 20 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809463immunoglobulin G, human 5 % per 200 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809447immunoglobulin G, human 5 % per 50 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809456immunoglobulin G, human 5 GM per 100 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809643Octagam 1 GM per 20 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809649Octagam 10 GM per 200 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809647Octagam 2.5 GM per 50 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809648Octagam 5 % per 100 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809643Octagam 5 % per 20 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809649Octagam 5 % per 200 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809647Octagam 5 % per 50 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043
1809648Octagam 5 GM per 100 ML InjectionSYfb07257b-e5e2-64c8-666c-65009f0aa6043

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0069-8400-010006984000120 mL in 1 BOTTLE, GLASS20 mlHistorical
0069-8400-02000698400021 BOTTLE, GLASS in 1 CARTON (0069-8400-02) / 20 mL in 1 BOTTLE, GLASS (0069-8400-01) 2023-11-13NoNoHistorical