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NDC 00069-8400-01 Octagam Immune Globulin (Human) 50 mg/mL Details
Octagam Immune Globulin (Human) 50 mg/mL
Octagam Immune Globulin (Human) is a INTRAVENOUS SOLUTION in the PLASMA DERIVATIVE category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is HUMAN IMMUNOGLOBULIN G.
Product Information
| NDC | 00069-8400 |
|---|---|
| Product ID | 0069-8400_6baea0c5-068c-ff76-8742-300979398c00 |
| Associated GPIs | |
| GCN Sequence Number | 073515 |
| GCN Sequence Number Description | immun globG(IgG)/malt/IgA ov50 VIAL 5 % INTRAVEN |
| HIC3 | W7K |
| HIC3 Description | ANTISERA |
| GCN | 37919 |
| HICL Sequence Number | 041764 |
| HICL Sequence Number Description | IMMUNE GLOBULIN,GAMM(IGG)/MALTOSE/IGA GREATER THAN 50 MCG/ML |
| Brand/Generic | Brand |
| Proprietary Name | Octagam Immune Globulin (Human) |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Immune Globulin |
| Product Type | PLASMA DERIVATIVE |
| Dosage Form | SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | HUMAN IMMUNOGLOBULIN G |
| Labeler Name | Pfizer Laboratories Div Pfizer Inc |
| Pharmaceutical Class | Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125062 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00069-8400-01 (00069840001)
| NDC Package Code | 0069-8400-01 |
|---|---|
| Billing NDC | 00069840001 |
| Package | 20 mL in 1 BOTTLE, GLASS (0069-8400-01) |
| Marketing Start Date | 2023-11-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |