NDC 0944-3945 - HEMOFIL M
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0944-3945
- Package NDCs from labels
- 0944-3945-01
- Manufacturer
- Takeda Pharmaceuticals America, Inc. | BAXALTA US Inc.
- Effective date
- 2025-03-06
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| HEMOFIL M - Takeda Pharmaceuticals America, Inc. | BAXALTA US Inc. | Takeda Pharmaceuticals America, Inc. | BAXALTA US Inc. | 2025-03-06 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0944-3945-01 | HEMOFIL M | 10 mL in 1 BOTTLE | POWDER, FOR SOLUTION | 10 mL | 1000 [iU] in 10mL | 15 |
DailyMed Dashboard NDC Coverage#
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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Premasol - sulfite-free (Amino Acid) | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE | Baxter Healthcare Company | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b | 2022-08-04 | Boxed warning, Warnings, Adverse reactions | 4QD397987E |
| Good Sense Clear Lax | POLYETHYLENE GLYCOL 3350 | Proficient Rx LP | 0858a914-4812-4e4d-82f8-ecf93d43ef3b | 2022-07-01 | Warnings | G2M7P15E5P |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| GAVILAX | POLYETHYLENE GLYCOL 3350 | Proficient Rx LP | 199d6173-3fad-49e4-88fe-bde7223ed4c3 | 2022-06-01 | Warnings | G2M7P15E5P |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| Polyethylene Glycol | POLYETHYLENE GLYCOL | BluePoint Laboratories | c4cae70c-68da-0bbc-e053-2a95a90a395a | 2021-09-20 | Warnings | G2M7P15E5P |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
| signature care clearlax | POLYETHYLENE GLYCOL 3350 | Safeway | 91d2e780-2aae-411c-b7b3-820302f0f63e | 2021-05-13 | Warnings | G2M7P15E5P |
| CLINIMIX E | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE | Baxter Healthcare Company | 8469d6fb-d6ef-476f-8cc3-0905192de0a8 | 2021-04-13 | Warnings, Adverse reactions | 4QD397987E |
| CLINIMIX | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE | Baxter Healthcare Corporation | dccff103-8695-400c-a15d-cc2fd078760a | 2021-04-13 | Warnings, Adverse reactions | 4QD397987E |
| Sterile Water | WATER | Asclemed USA, Inc. | 45c38269-883c-4198-a9d5-03810a4420ec | 2021-01-14 | Warnings, Adverse reactions | 059QF0KO0R |
| Travasol | LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE | Baxter Healthcare Corporation | 8543b5be-0f43-4891-9e56-d7c39fe839b5 | 2020-10-07 | Warnings, Adverse reactions | 4QD397987E |
| Bach Original Flower Remedies | WATER | Nelson Bach USA Limited | 09c76050-42c5-4403-865c-a1f6f668d9c0 | 2020-06-15 | Warnings | 059QF0KO0R |
| POLYETHYLENE GLYCOL 3350 NF | POLYETHYLENE GLYCOL 3350 | SUNRISE PHARMACEUTICAL, INC | ce5197a1-2677-4ffb-aef2-9221b28ebd23 | 2020-01-22 | Warnings | G2M7P15E5P |
| Sterile Water | WATER | Baxter Healthcare Company | 8bcf5572-49e1-4302-9522-56f57904cb4a | 2019-12-29 | Warnings, Adverse reactions | 059QF0KO0R |
| Dynamic Eyewash with Eyecup | WATER | Dynamic Safety International | 7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2 | 2018-12-17 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.