ADVATE
- Product NDC
- 0944-3054
- 11-digit product format
- 009443054
- Labeler code
- 0944
- Product ID
- 0944-3054_13243ff1-40ce-41c2-964d-279a9ec57595
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Antihemophilic Factor (Recombinant)
- Dosage form
- KIT
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA125063
- Marketing category
- BLA
- Marketing start
- 2011-12-15
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ADVATE
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0944-2944-02 | ADVATE | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 750 [iU] in 1mL | 13 |
| 0944-3054-02 | ADVATE | 1 in 1 CARTON | KIT | 1 | | 13 |
| 0944-3054-03 | ADVATE | 1 in 1 BLISTER PACK | KIT | 1 | | 13 |
| 0944-3054-04 | ADVATE | 1 in 1 CONTAINER | KIT | 1 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT | ACTIVE INGREDIENT | P89DR4NY54 | ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 2 | |
| ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT | ACTIVE MOIETY | P89DR4NY54 | ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 2 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 2 | |
| GLUTATHIONE | INACTIVE INGREDIENT | GAN16C9B8O | ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 2 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 2 | |
| TREHALOSE | INACTIVE INGREDIENT | B8WCK70T7I | ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 2 | |
| TROMETHAMINE | INACTIVE INGREDIENT | 023C2WHX2V | ADVATE (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0944-3054 | ADVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 13 | Current NDC, Legacy NDC, 4 package rows | 20250418_80fa03d2-cd4c-4155-9b57-1396c4fa42da.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0944-2944-02 | 00944294402 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | | Historical |
| 0944-3054-02 | 00944305402 | 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) | 1 blister pack | 2011-12-15 | 0000-00-00 | No | No | Current |
| 0944-3054-03 | 00944305403 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 0944-3054-04 | 00944305404 | 1 in 1 CONTAINER | | | | | | Historical |