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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0944-3946-02 | EA - Each | 0944-3946 | 6a5004d0-5b9b-445b-9e1f-1be9fd7d2e49 | 1 | 2013-08-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ANTIHEMOPHILIC FACTOR HUMAN | ACTIVE INGREDIENT | 839MOZ74GK | HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION] | 9 | |
| ANTIHEMOPHILIC FACTOR HUMAN | ACTIVE MOIETY | 839MOZ74GK | HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION] | 9 | |
| ALBUMIN HUMAN | INACTIVE INGREDIENT | ZIF514RVZR | HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION] | 9 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION] | 9 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION] | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1718962 | antihemophilic factor, human 1 UNT Injection | PSN | b8953ff7-3bba-4a0b-a486-f26fb81f05d9 | 15 |
| 1718965 | Hemofil M 1 UNT Injection | PSN | b8953ff7-3bba-4a0b-a486-f26fb81f05d9 | 15 |
| 1718965 | antihemophilic factor, human 1 UNT Injection [Hemofil] | SBD | b8953ff7-3bba-4a0b-a486-f26fb81f05d9 | 15 |
| 1718962 | antihemophilic factor, human 1 UNT Injection | SCD | b8953ff7-3bba-4a0b-a486-f26fb81f05d9 | 15 |
| 1718962 | factor VIII, human 1 UNT Injection | SY | b8953ff7-3bba-4a0b-a486-f26fb81f05d9 | 15 |
| 1718965 | Hemofil M 1 UNT Injection | SY | b8953ff7-3bba-4a0b-a486-f26fb81f05d9 | 15 |
Packages#
| 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 |