NDC 70860-216

Busulfan

Busulfan

Busulfan is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Athenex Pharmaceutical Division, Llc.. The primary component is Busulfan.

• Product ID: 70860-216_8189e34d-4b3d-4a39-a42f-870cfd05baaf
• NDC: 70860-216
• Product Type: Human Prescription Drug
• Proprietary Name: Busulfan
• Generic Name: Busulfan
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-02-10
• Marketing End Date: 2021-07-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205106
• Labeler Name: Athenex Pharmaceutical Division, LLC.
• Substance Name: BUSULFAN
• Active Ingredient Strength: 6 mg/mL
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N

Packaging

NDC 70860-216-10

8 VIAL in 1 CARTON (70860-216-10) > 10 mL in 1 VIAL (70860-216-41)

• Marketing Start Date: 2019-02-10
• Marketing End Date: 2021-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70860-216-41 [70860021641]

Busulfan INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA205106
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-02-10

NDC 70860-216-10 [70860021610]

Busulfan INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA205106
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-02-10

Drug Details

Active Ingredients

Ingredient	Strength
BUSULFAN	6 mg/mL

OpenFDA Data

• SPL SET ID: 5eb97384-3dc0-4172-9ffc-693be91077dc
• Manufacturer:
  • Athenex Pharmaceutical Division, LLC.
• UNII:
  • G1LN9045DK
• RxNorm Concept Unique ID - RxCUI:
  • 253113

Pharmacological Class

• Alkylating Activity [MoA]
• Alkylating Drug [EPC]
• Alkylating Activity [MoA]
• Alkylating Drug [EPC]

NDC Crossover Matching brand name "Busulfan" or generic name "Busulfan"

NDC	Brand Name	Generic Name
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
59148-047	BUSULFEX	busulfan
59148-070	BUSULFEX	busulfan
69784-620	MYLERAN	busulfan
76388-713	MYLERAN	busulfan
0517-0920	N/A	busulfan