FDA.reportPublic FDA data

Octagam Immune Globulin (Human)

Product NDC
0069-6550
11-digit product format
000696550
Labeler code
0069
Product ID
0069-6550_86003c7c-517c-9c41-8960-cace21be471c
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
100 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 G100 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-6550-01Octagam Immune Globulin (Human)50 mL in 1 BOTTLE, GLASSSOLUTION502
0069-6550-02Octagam Immune Globulin (Human)1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-6550-01ML - Milliliter0069-6550a008354e-5c02-4082-beed-54074fa9e26a12023-12-05
0069-6550-02ML - Milliliter0069-65503e56ec4b-6b8f-4c55-be55-1d3aae2427a412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-6550OCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]2Current NDC, 2 package rows20240127_eb4c342b-122c-0072-1428-1747882e6c00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809421immunoglobulin G, human 10 % in 100 ML InjectionPSNeb4c342b-122c-0072-1428-1747882e6c002
1809497immunoglobulin G, human 10 % in 20 ML InjectionPSNeb4c342b-122c-0072-1428-1747882e6c002
1809444immunoglobulin G, human 10 % in 200 ML InjectionPSNeb4c342b-122c-0072-1428-1747882e6c002
1809539immunoglobulin G, human 10 % in 300 ML InjectionPSNeb4c342b-122c-0072-1428-1747882e6c002
1809414immunoglobulin G, human 10 % in 50 ML InjectionPSNeb4c342b-122c-0072-1428-1747882e6c002
1809502octagam 10 % in 100 ML InjectionPSNeb4c342b-122c-0072-1428-1747882e6c002
1809499octagam 10 % in 20 ML InjectionPSNeb4c342b-122c-0072-1428-1747882e6c002
1809503octagam 10 % in 200 ML InjectionPSNeb4c342b-122c-0072-1428-1747882e6c002
2170634octagam 10 % in 300 ML InjectionPSNeb4c342b-122c-0072-1428-1747882e6c002
1809501octagam 10 % in 50 ML InjectionPSNeb4c342b-122c-0072-1428-1747882e6c002
1809502100 ML immunoglobulin G, human 100 MG/ML Injection [Octagam]SBDeb4c342b-122c-0072-1428-1747882e6c002
180949920 ML immunoglobulin G, human 100 MG/ML Injection [Octagam]SBDeb4c342b-122c-0072-1428-1747882e6c002
1809503200 ML immunoglobulin G, human 100 MG/ML Injection [Octagam]SBDeb4c342b-122c-0072-1428-1747882e6c002
2170634300 ML immunoglobulin G, human 100 MG/ML Injection [Octagam]SBDeb4c342b-122c-0072-1428-1747882e6c002
180950150 ML immunoglobulin G, human 100 MG/ML Injection [Octagam]SBDeb4c342b-122c-0072-1428-1747882e6c002
1809421100 ML immunoglobulin G, human 100 MG/ML InjectionSCDeb4c342b-122c-0072-1428-1747882e6c002
180949720 ML immunoglobulin G, human 100 MG/ML InjectionSCDeb4c342b-122c-0072-1428-1747882e6c002
1809444200 ML immunoglobulin G, human 100 MG/ML InjectionSCDeb4c342b-122c-0072-1428-1747882e6c002
1809539300 ML immunoglobulin G, human 100 MG/ML InjectionSCDeb4c342b-122c-0072-1428-1747882e6c002
180941450 ML immunoglobulin G, human 100 MG/ML InjectionSCDeb4c342b-122c-0072-1428-1747882e6c002
1809502100 ML Octagam 100 MG/ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
180949920 ML Octagam 100 MG/ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809503200 ML Octagam 100 MG/ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
2170634300 ML Octagam 100 MG/ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
180950150 ML Octagam 100 MG/ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809421immunoglobulin G, human 10 % per 100 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809497immunoglobulin G, human 10 % per 20 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809444immunoglobulin G, human 10 % per 200 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809539immunoglobulin G, human 10 % per 300 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809414immunoglobulin G, human 10 % per 50 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809421immunoglobulin G, human 10 GM per 100 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809497immunoglobulin G, human 2 GM per 20 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809444immunoglobulin G, human 20 GM per 200 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809414immunoglobulin G, human 5 GM per 50 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809502Octagam 10 % per 100 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809499Octagam 10 % per 20 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809503Octagam 10 % per 200 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
2170634octagam 10 % per 300 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809501Octagam 10 % per 50 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809502Octagam 10 GM per 100 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809499Octagam 2 GM per 20 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809503Octagam 20 GM per 200 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002
1809501Octagam 5 GM per 50 ML InjectionSYeb4c342b-122c-0072-1428-1747882e6c002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0069-6550-010006965500150 mL in 1 BOTTLE, GLASS50 mlHistorical
0069-6550-02000696550021 BOTTLE, GLASS in 1 CARTON (0069-6550-02) / 50 mL in 1 BOTTLE, GLASS (0069-6550-01) 2023-11-13NoNoHistorical