HEMOFIL M
- Product NDC
- 0944-3946
- 11-digit product format
- 009443946
- Labeler code
- 0944
- Product ID
- 0944-3946_15c108eb-91a2-4058-9d08-cc1168ee741d
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- antihemophilic factor human
- Dosage form
- KIT
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA101448
- Marketing category
- BLA
- Marketing start
- 1988-02-23
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HEMOFIL M
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0944-3946-02 | HEMOFIL M | 1 in 1 CARTON | KIT | 1 | | 15 |
| 0944-3947-01 | HEMOFIL M | 10 mL in 1 BOTTLE | POWDER, FOR SOLUTION | 10 mL | 1700 [iU] in 10mL | 15 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0944-3946 | HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20250309_b8953ff7-3bba-4a0b-a486-f26fb81f05d9.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 101448 | Hemofil M | Antihemophilic Factor (Human) | 351(a) | Rx | 2026-06-01 |
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 |
|---|
| 0944-3946-02 | 00944394602 | 1 KIT in 1 CARTON (0944-3946-02) * 10 mL in 1 BOTTLE (0944-3947-01) * 10 mL in 1 VIAL, GLASS (64764-516-10) | 1 kit | 1988-02-23 | 0000-00-00 | No | No | Current |
| 0944-3947-01 | 00944394701 | 10 mL in 1 BOTTLE | 10 ml | | | | | Historical |