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NDC 00944-4628-01 ADYNOVATE Details
ADYNOVATE
ADYNOVATE is a KIT in the PLASMA DERIVATIVE category. It is labeled and distributed by Takeda Pharmaceuticals Amercia, Inc.. The primary component is .
Product Information
| NDC | 00944-4628 |
|---|---|
| Product ID | 0944-4628_215d2368-3d55-4bf5-adce-cc4d43c566f6 |
| Associated GPIs | 85100010402160 |
| GCN Sequence Number | 077369 |
| GCN Sequence Number Description | antihemo.FVIII,full length peg VIAL 3000 (+/-) INTRAVEN |
| HIC3 | M0E |
| HIC3 Description | ANTIHEMOPHILIC FACTORS |
| GCN | 43353 |
| HICL Sequence Number | 042832 |
| HICL Sequence Number Description | ANTIHEMOPHILIC FACTOR (FVIII) RECOMBINANT, FULL LENGTH, PEG |
| Brand/Generic | Brand |
| Proprietary Name | ADYNOVATE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Antihemophilic Factor (Recombinant) PEGylated |
| 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 Amercia, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125566 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00944-4628-01 (00944462801)
| NDC Package Code | 0944-4628-01 |
|---|---|
| Billing NDC | 00944462801 |
| Package | 1 KIT in 1 CARTON (0944-4628-01) / 1 CONTAINER in 1 KIT (0944-4628-02) / 1 KIT in 1 CONTAINER (0944-4628-03) * 5 mL in 1 VIAL, GLASS (64764-515-50) * 5 mL in 1 VIAL, GLASS (0944-4263-01) |
| Marketing Start Date | 2016-10-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |