FDA.reportPublic FDA data

Octagam Immune Globulin (Human)

Product NDC
68209-843
11-digit product format
682090843
Labeler code
68209
Product ID
68209-843_0e0a702d-888c-e29e-e8bf-9910b8719d1c
Type
PLASMA DERIVATIVE
Nonproprietary name
Immune Globulin
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Octapharma AB
Application
BLA125062
Marketing category
BLA
Marketing start
2006-04-14
Marketing end
0000-00-00
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
50 mg/mL
Pharmacologic classes
Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68209-843IInactivated by FDA2026-08-03
excluded packagepackage68209-84368209-843-01IInactivated by FDA2026-08-03
excluded packagepackage68209-84368209-843-02IInactivated by FDA2026-08-03
excluded packagepackage68209-84368209-843-03IInactivated by FDA2026-08-03
excluded packagepackage68209-84368209-843-04IInactivated by FDA2026-08-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68209-843-012019-11-27C16284748780-19855d018-dfa0-cd31-e053-dbdaa90ab51aOctagam, Immune Globulin Intravenous (Human) 5% Liquid Preparation Initial U.S. Approval: 2004 - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.
68209-843-022019-11-27C16284748780-19855d018-dfa0-cd31-e053-dbdaa90ab51aOctagam, Immune Globulin Intravenous (Human) 5% Liquid Preparation Initial U.S. Approval: 2004 - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.
68209-843-032019-11-27C16284748780-19855d018-dfa0-cd31-e053-dbdaa90ab51aOctagam, Immune Globulin Intravenous (Human) 5% Liquid Preparation Initial U.S. Approval: 2004 - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.
68209-843-042019-11-27C16284748780-19855d018-dfa0-cd31-e053-dbdaa90ab51aOctagam, Immune Globulin Intravenous (Human) 5% Liquid Preparation Initial U.S. Approval: 2004 - These highlights do not include all the information needed to use Octagam, Immune Globulin Intravenous (Human), safely and effectively. See full prescribing information for Octagam.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68209-843-01Octagam Immune Globulin (Human)20 mL in 1 BOTTLE, GLASSSOLUTION201
68209-843-02Octagam Immune Globulin (Human)50 mL in 1 BOTTLE, GLASSSOLUTION501
68209-843-03Octagam Immune Globulin (Human)100 mL in 1 BOTTLE, GLASSSOLUTION1001
68209-843-04Octagam Immune Globulin (Human)200 mL in 1 BOTTLE, GLASSSOLUTION2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68209-843-01ML - Milliliter68209-843db309ad0-85da-4898-9f95-d4033e4358ef12013-03-03
68209-843-02ML - Milliliter68209-8434a29c60f-90bb-402b-8f52-6a09701bd74612013-02-13
68209-843-03ML - Milliliter68209-843fd7cfc68-6ac7-417c-8642-1daf19282d3212013-02-13
68209-843-04ML - Milliliter68209-8437eeef9e7-897f-480c-a6b5-4492c7658f9a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN IMMUNOGLOBULIN GACTIVE INGREDIENT66Y330CJHSOCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [OCTAPHARMA AB]1
HUMAN IMMUNOGLOBULIN GACTIVE MOIETY66Y330CJHSOCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [OCTAPHARMA AB]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68209-843OCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [OCTAPHARMA AB]1Legacy NDC, 4 package rows20121004_c906fa75-6235-032a-284f-cd0b93794ff9.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125062OctagamImmune Globulin Intravenous (Human)351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809644immunoglobulin G, human 50 MG/ML Injection [Octagam]SBDc906fa75-6235-032a-284f-cd0b93794ff91
1809430immunoglobulin G, human 50 MG/ML InjectionSCDc906fa75-6235-032a-284f-cd0b93794ff91
1809430immunoglobulin G, human 5 % InjectionSYc906fa75-6235-032a-284f-cd0b93794ff91
1809644Octagam 50 MG/ML InjectionSYc906fa75-6235-032a-284f-cd0b93794ff91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68209-843-016820908430120 mL in 1 BOTTLE, GLASS20 mlHistorical
68209-843-026820908430250 mL in 1 BOTTLE, GLASS50 mlHistorical
68209-843-0368209084303100 mL in 1 BOTTLE, GLASS100 mlHistorical
68209-843-0468209084304200 mL in 1 BOTTLE, GLASS200 mlHistorical