FDA.reportPublic FDA data

Octagam Immune Globulin (Human)

Product NDC
68982-850
11-digit product format
689820850
Labeler code
68982
Product ID
68982-850_3341403e-ae11-5eae-adf5-63ebc0703d25
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
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
68982-850-01Octagam Immune Globulin (Human)20 mL in 1 BOTTLE, GLASSSOLUTION2021
68982-850-02Octagam Immune Globulin (Human)50 mL in 1 BOTTLE, GLASSSOLUTION5021
68982-850-03Octagam Immune Globulin (Human)100 mL in 1 BOTTLE, GLASSSOLUTION10021
68982-850-04Octagam Immune Globulin (Human)200 mL in 1 BOTTLE, GLASSSOLUTION20021
68982-850-05Octagam Immune Globulin (Human)300 mL in 1 BOTTLE, GLASSSOLUTION30021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68982-850-01ML - Milliliter68982-8502e2a2d16-5d32-4764-9f74-5bc8f1e3872212015-01-05
68982-850-02ML - Milliliter68982-850b553837a-b437-4656-81f1-9858647a65aa12015-01-05
68982-850-03ML - Milliliter68982-85084b19ac3-b99d-4cbc-a25b-32e3b0fbd38312015-01-05
68982-850-04ML - Milliliter68982-850bf788587-40fd-4daa-bdd6-bcd082a1c56f12015-01-05
68982-850-05ML - Milliliter68982-85088c3fb84-379b-451e-8623-6464147ffae812019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN IMMUNOGLOBULIN GACTIVE INGREDIENT66Y330CJHSOCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [OCTAPHARMA USA INC]5
HUMAN IMMUNOGLOBULIN GACTIVE MOIETY66Y330CJHSOCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [OCTAPHARMA USA INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-850OCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [OCTAPHARMA USA INC]21Current NDC, Legacy NDC, 5 package rows20220407_a36a12dc-16be-b135-466f-393954f428a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809421immunoglobulin G, human 10 % in 100 ML InjectionPSNa36a12dc-16be-b135-466f-393954f428a721
1809497immunoglobulin G, human 10 % in 20 ML InjectionPSNa36a12dc-16be-b135-466f-393954f428a721
1809444immunoglobulin G, human 10 % in 200 ML InjectionPSNa36a12dc-16be-b135-466f-393954f428a721
1809539immunoglobulin G, human 10 % in 300 ML InjectionPSNa36a12dc-16be-b135-466f-393954f428a721
1809414immunoglobulin G, human 10 % in 50 ML InjectionPSNa36a12dc-16be-b135-466f-393954f428a721
1809502octagam 10 % in 100 ML InjectionPSNa36a12dc-16be-b135-466f-393954f428a721
1809499octagam 10 % in 20 ML InjectionPSNa36a12dc-16be-b135-466f-393954f428a721
1809503octagam 10 % in 200 ML InjectionPSNa36a12dc-16be-b135-466f-393954f428a721
2170634octagam 10 % in 300 ML InjectionPSNa36a12dc-16be-b135-466f-393954f428a721
1809501octagam 10 % in 50 ML InjectionPSNa36a12dc-16be-b135-466f-393954f428a721
1809502100 ML immunoglobulin G, human 100 MG/ML Injection [Octagam]SBDa36a12dc-16be-b135-466f-393954f428a721
180949920 ML immunoglobulin G, human 100 MG/ML Injection [Octagam]SBDa36a12dc-16be-b135-466f-393954f428a721
1809503200 ML immunoglobulin G, human 100 MG/ML Injection [Octagam]SBDa36a12dc-16be-b135-466f-393954f428a721
2170634300 ML immunoglobulin G, human 100 MG/ML Injection [Octagam]SBDa36a12dc-16be-b135-466f-393954f428a721
180950150 ML immunoglobulin G, human 100 MG/ML Injection [Octagam]SBDa36a12dc-16be-b135-466f-393954f428a721
1809421100 ML immunoglobulin G, human 100 MG/ML InjectionSCDa36a12dc-16be-b135-466f-393954f428a721
180949720 ML immunoglobulin G, human 100 MG/ML InjectionSCDa36a12dc-16be-b135-466f-393954f428a721
1809444200 ML immunoglobulin G, human 100 MG/ML InjectionSCDa36a12dc-16be-b135-466f-393954f428a721
1809539300 ML immunoglobulin G, human 100 MG/ML InjectionSCDa36a12dc-16be-b135-466f-393954f428a721
180941450 ML immunoglobulin G, human 100 MG/ML InjectionSCDa36a12dc-16be-b135-466f-393954f428a721
1809502100 ML Octagam 100 MG/ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
180949920 ML Octagam 100 MG/ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809503200 ML Octagam 100 MG/ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
2170634300 ML Octagam 100 MG/ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
180950150 ML Octagam 100 MG/ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809421immunoglobulin G, human 10 % per 100 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809497immunoglobulin G, human 10 % per 20 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809444immunoglobulin G, human 10 % per 200 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809539immunoglobulin G, human 10 % per 300 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809414immunoglobulin G, human 10 % per 50 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809421immunoglobulin G, human 10 GM per 100 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809497immunoglobulin G, human 2 GM per 20 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809444immunoglobulin G, human 20 GM per 200 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809414immunoglobulin G, human 5 GM per 50 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809502Octagam 10 % per 100 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809499Octagam 10 % per 20 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809503Octagam 10 % per 200 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
2170634octagam 10 % per 300 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809501Octagam 10 % per 50 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809502Octagam 10 GM per 100 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809499Octagam 2 GM per 20 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809503Octagam 20 GM per 200 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721
1809501Octagam 5 GM per 50 ML InjectionSYa36a12dc-16be-b135-466f-393954f428a721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68982-850-016898208500120 mL in 1 BOTTLE, GLASS (68982-850-01) 20 ml2004-05-210000-00-00NoNoCurrent
68982-850-026898208500250 mL in 1 BOTTLE, GLASS (68982-850-02) 50 ml2004-05-210000-00-00NoNoCurrent
68982-850-0368982085003100 mL in 1 BOTTLE, GLASS (68982-850-03) 100 ml2004-05-210000-00-00NoNoCurrent
68982-850-0468982085004200 mL in 1 BOTTLE, GLASS (68982-850-04) 200 ml2004-05-210000-00-00NoNoCurrent
68982-850-0568982085005300 mL in 1 BOTTLE, GLASS (68982-850-05) 300 ml2004-05-210000-00-00NoNoCurrent