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NDC 75833-0601-02 Hepzato Kit Details
Hepzato Kit
Hepzato Kit is a INTRA-ARTERIAL KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Delcath Systems, Inc.. The primary component is .
Product Information
| NDC | 75833-0601 |
|---|---|
| Product ID | 75833-601_2685e427-20bd-46f5-85a9-85dac091ea36 |
| 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 | Hepzato Kit |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | melphalan hydrochloride injection, powder, lyophilized, for solution |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | KIT |
| Route | INTRA-ARTERIAL |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Delcath Systems, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA201848 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 75833-0601-02 (75833060102)
| NDC Package Code | 75833-601-02 |
|---|---|
| Billing NDC | 75833060102 |
| Package | 1 KIT in 1 BOX (75833-601-02) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2023-12-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |