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NDC 00944-5001-10 OBIZUR Details
OBIZUR
OBIZUR is a KIT in the PLASMA DERIVATIVE category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is .
Product Information
| NDC | 00944-5001 |
|---|---|
| Product ID | 0944-5001_6bf6b16a-d0f3-4643-b491-e75fa0f98ac5 |
| Associated GPIs | 85100010502130 |
| GCN Sequence Number | 073007 |
| GCN Sequence Number Description | antihemophilic FVIII,rec porc VIAL 500 (+/-) INTRAVEN |
| HIC3 | M0E |
| HIC3 Description | ANTIHEMOPHILIC FACTORS |
| GCN | 37321 |
| HICL Sequence Number | 041515 |
| HICL Sequence Number Description | ANTIHEMOPHILIC FACTOR VIII, RECOMBINANT PORCINE SEQUENCE |
| Brand/Generic | Brand |
| Proprietary Name | OBIZUR |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Antihemophilic Factor (Recombinant), Porcine Sequence |
| Product Type | PLASMA DERIVATIVE |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125512 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00944-5001-10 (00944500110)
| NDC Package Code | 0944-5001-10 |
|---|---|
| Billing NDC | 00944500110 |
| Package | 10 CARTON in 1 CARTON (0944-5001-10) / 1 KIT in 1 CARTON (0944-5001-01) * 1 mL in 1 VIAL, GLASS (0944-5011-01) * 1 mL in 1 SYRINGE, GLASS (0944-0011-01) |
| Marketing Start Date | 2014-10-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |