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NDC 00944-3054-02 ADVATE Details
ADVATE
ADVATE 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 | 00944-3054 |
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Product ID | 0944-3054_e3808f08-3c70-4d96-81a9-519f9d384951 |
Associated GPIs | 85100010252150 |
GCN Sequence Number | 063070 |
GCN Sequence Number Description | antihemophil.FVIII,full length VIAL 1500 (+/-) INTRAVEN |
HIC3 | M0E |
HIC3 Description | ANTIHEMOPHILIC FACTORS |
GCN | 98830 |
HICL Sequence Number | 041651 |
HICL Sequence Number Description | ANTIHEMOPHILIC FACTOR (FVIII) RECOMBINANT,FULL LENGTH |
Brand/Generic | Brand |
Proprietary Name | ADVATE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Antihemophilic Factor (Recombinant) |
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 | BLA125063 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00944-3054-02 (00944305402)
NDC Package Code | 0944-3054-02 |
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Billing NDC | 00944305402 |
Package | 1 BLISTER PACK in 1 CARTON (0944-3054-02) / 1 CONTAINER in 1 BLISTER PACK (0944-3054-03) / 1 KIT in 1 CONTAINER (0944-3054-04) * 5 mL in 1 VIAL, GLASS (0944-2944-02) * 2 mL in 1 VIAL, GLASS (64764-514-02) |
Marketing Start Date | 2011-12-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |