Octagam Immune Globulin (Human)
- Product NDC
- 67467-843
- 11-digit product format
- 674670843
- Labeler code
- 67467
- Product ID
- 67467-843_0fe33130-c3e4-4baa-db1f-4ce138e6c2e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Immune Globulin
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
- Application
- BLA125062
- Marketing category
- BLA
- Marketing start
- 2004-05-21
- 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
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 67467-843-01 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c6a2-621f-e053-dbdaa90a74ad | Octagam, 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. |
| 67467-843-02 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c6a2-621f-e053-dbdaa90a74ad | Octagam, 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. |
| 67467-843-03 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c6a2-621f-e053-dbdaa90a74ad | Octagam, 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. |
| 67467-843-04 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c6a2-621f-e053-dbdaa90a74ad | Octagam, 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. |
| 67467-843-05 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c6a2-621f-e053-dbdaa90a74ad | Octagam, 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 NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67467-843-01 | Octagam Immune Globulin (Human) | 20 mL in 1 BOTTLE, GLASS | SOLUTION | 20 | | 4 |
| 67467-843-02 | Octagam Immune Globulin (Human) | 50 mL in 1 BOTTLE, GLASS | SOLUTION | 50 | | 4 |
| 67467-843-03 | Octagam Immune Globulin (Human) | 100 mL in 1 BOTTLE, GLASS | SOLUTION | 100 | | 4 |
| 67467-843-04 | Octagam Immune Globulin (Human) | 200 mL in 1 BOTTLE, GLASS | SOLUTION | 200 | | 4 |
| 67467-843-05 | Octagam Immune Globulin (Human) | 500 mL in 1 BOTTLE, GLASS | SOLUTION | 500 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67467-843 | OCTAGAM IMMUNE GLOBULIN (HUMAN) (IMMUNE GLOBULIN) SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.] | 4 | Legacy NDC, 5 package rows | 20100809_810c8752-a7cb-0bce-777d-8539429773c2.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125062 | Octagam | Immune Globulin Intravenous (Human) | 351(a) | Rx | 2026-06-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 67467-843-01 | 67467084301 | 20 mL in 1 BOTTLE, GLASS | 20 ml | Historical |
| 67467-843-02 | 67467084302 | 50 mL in 1 BOTTLE, GLASS | 50 ml | Historical |
| 67467-843-03 | 67467084303 | 100 mL in 1 BOTTLE, GLASS | 100 ml | Historical |
| 67467-843-04 | 67467084304 | 200 mL in 1 BOTTLE, GLASS | 200 ml | Historical |
| 67467-843-05 | 67467084305 | 500 mL in 1 BOTTLE, GLASS | 500 ml | Historical |