NDC 59148-047
BUSULFEX
Busulfan
BUSULFEX is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc.. The primary component is Busulfan.
| Product ID | 59148-047_7bce580d-c1ee-13e3-e053-2a91aa0aa6bd |
| NDC | 59148-047 |
| Product Type | Human Prescription Drug |
| Proprietary Name | BUSULFEX |
| Generic Name | Busulfan |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2015-02-13 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020954 |
| Labeler Name | Otsuka America Pharmaceutical, Inc. |
| Substance Name | BUSULFAN |
| Active Ingredient Strength | 6 mg/mL |
| Pharm Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 59148-047-91
8 VIAL in 1 PACKAGE (59148-047-91) > 10 mL in 1 VIAL (59148-047-90)
| Marketing Start Date | 2015-02-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 59148-047-91 [59148004791]
BUSULFEX INJECTION
| Marketing Category | NDA |
| Application Number | NDA020954 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2015-02-13 |
| Marketing End Date | 2021-01-31 |
NDC 59148-047-90 [59148004790]
BUSULFEX INJECTION
| Marketing Category | NDA |
| Application Number | NDA020954 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2015-02-13 |
| Marketing End Date | 2021-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BUSULFAN | 6 mg/mL |
OpenFDA Data
| SPL SET ID: | e03a2579-fb59-4c77-b487-0a72cb8cd76e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Alkylating Activity [MoA]
- Alkylating Drug [EPC]
NDC Crossover Matching brand name "BUSULFEX" or generic name "Busulfan"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 59148-047 | BUSULFEX | busulfan |
| 59148-070 | BUSULFEX | busulfan |
| 0409-1112 | BUSULFAN | BUSULFAN |
| 16729-351 | Busulfan | busulfan |
| 25021-241 | Busulfan | Busulfan |
| 45963-640 | Busulfan | Busulfan |
| 51817-170 | Busulfan | busulfan |
| 60505-6177 | Busulfan | busulfan |
| 65219-160 | Busulfan | Busulfan |
| 67457-893 | Busulfan | Busulfan |
| 70121-1244 | Busulfan | Busulfan |
| 70860-216 | Busulfan | busulfan |
| 71288-116 | Busulfan | Busulfan |
| 71288-158 | Busulfan | Busulfan |
| 72485-210 | Busulfan | Busulfan |
| 72606-559 | Busulfan | Busulfan |
| 69784-620 | MYLERAN | busulfan |
| 76388-713 | MYLERAN | busulfan |
| 0517-0920 | N/A | busulfan |
Trademark Results [BUSULFEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BUSULFEX 75252920 2254101 Live/Registered |
OTSUKA PHARMACEUTICAL CO., LTD. 1997-03-06 |
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