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NDC 00053-0170-17 HEMGENIX Details
HEMGENIX
HEMGENIX is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by CSL Behring. The primary component is .
Product Information
NDC | 00053-0170 |
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Product ID | 0053-0170_37461df8-e3a4-4052-bcf5-eb1e5cc56de1 |
Associated GPIs | |
GCN Sequence Number | 084084 |
GCN Sequence Number Description | etranacogene dezaparvovec-drlb KIT 1X10E13/ML INTRAVEN |
HIC3 | M0V |
HIC3 Description | GENE THERAPY AGENTS - FACTOR DEFICIENCY |
GCN | 53228 |
HICL Sequence Number | 048472 |
HICL Sequence Number Description | ETRANACOGENE DEZAPARVOVEC-DRLB |
Brand/Generic | Brand |
Proprietary Name | HEMGENIX |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | etranacogene dezaparvovec |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | KIT |
Route | n/a |
Active Ingredient Strength | n/a |
Active Ingredient Units | n/a |
Substance Name | n/a |
Labeler Name | CSL Behring |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125772 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00053-0170-17 (00053017017)
NDC Package Code | 0053-0170-17 |
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Billing NDC | 00053017017 |
Package | 1 KIT in 1 CARTON (0053-0170-17) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) |
Marketing Start Date | 2022-11-22 |
NDC Exclude Flag | N |
Pricing Information | N/A |