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NDC 61476-0104-05 Alyglo 100 mg/mL Details
Alyglo 100 mg/mL
Alyglo is a INTRAVENOUS LIQUID in the PLASMA DERIVATIVE category. It is labeled and distributed by GC Biopharma Corp.. The primary component is HUMAN IMMUNOGLOBULIN G.
Product Information
NDC | 61476-0104 |
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Product ID | 61476-104_692b3911-b195-4499-9790-37e0812b3cde |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Alyglo |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Human immunoglobulin G |
Product Type | PLASMA DERIVATIVE |
Dosage Form | LIQUID |
Route | INTRAVENOUS |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/mL |
Substance Name | HUMAN IMMUNOGLOBULIN G |
Labeler Name | GC Biopharma Corp. |
Pharmaceutical Class | Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125743 |
Listing Certified Through | 2024-12-31 |
Package
NDC 61476-0104-05 (61476010405)
NDC Package Code | 61476-104-05 |
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Billing NDC | 61476010405 |
Package | 1 VIAL, GLASS in 1 CARTON (61476-104-05) / 50 mL in 1 VIAL, GLASS (61476-104-01) |
Marketing Start Date | 2023-12-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |