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NDC 00053-0190-19 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 | 00053-0190 |
|---|---|
| Product ID | 0053-0190_37461df8-e3a4-4052-bcf5-eb1e5cc56de1 |
| Associated GPIs | |
| GCN Sequence Number | 084105 |
| GCN Sequence Number Description | etranacogene dezaparvovec-drlb KIT 1X10E13/ML INTRAVEN |
| HIC3 | M0V |
| HIC3 Description | GENE THERAPY AGENTS - FACTOR DEFICIENCY |
| GCN | 53252 |
| 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 00053-0190-19 (00053019019)
| NDC Package Code | 0053-0190-19 |
|---|---|
| Billing NDC | 00053019019 |
| Package | 1 KIT in 1 CARTON (0053-0190-19) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) |
| Marketing Start Date | 2022-11-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |