NDC 0517-0920

N/A

Busulfan

N/A is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Busulfan.

• Product ID: 0517-0920_11974653-8c95-483d-ac3e-66b4fede360e
• NDC: 0517-0920
• Product Type: Human Prescription Drug
• Proprietary Name: N/A
• Generic Name: Busulfan
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-04-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202259
• Labeler Name: American Regent, Inc.
• Substance Name: BUSULFAN
• Active Ingredient Strength: 6 mg/mL
• Pharm Classes: Alkylating Acti
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0517-0920-08

8 VIAL in 1 PACKAGE (0517-0920-08) > 10 mL in 1 VIAL (0517-0920-01)

• Marketing Start Date: 2017-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0517-0920-01 [00517092001]

BUSULFAN INJECTION

• Marketing Category: ANDA
• Application Number: ANDA202259
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-03-28

NDC 0517-0920-90 [00517092090]

BUSULFAN INJECTION

• Marketing Category: ANDA
• Application Number: ANDA202259
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-04-01
• Marketing End Date: 2016-03-28

NDC 0517-0920-08 [00517092008]

BUSULFAN INJECTION

• Marketing Category: ANDA
• Application Number: ANDA202259
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-04-01

NDC 0517-0920-91 [00517092091]

BUSULFAN INJECTION

• Marketing Category: ANDA
• Application Number: ANDA202259
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-04-01
• Marketing End Date: 2016-03-28

Drug Details

Active Ingredients

Ingredient	Strength
BUSULFAN	6 mg/mL

OpenFDA Data

• SPL SET ID: 060db20b-d889-48db-a034-83dc3811d723
• Manufacturer:
  • American Regent, Inc.
• UNII:
  • G1LN9045DK
• RxNorm Concept Unique ID - RxCUI:
  • 253113

Pharmacological Class

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

NDC Crossover Matching brand name "N/A" or generic name "Busulfan"

NDC	Brand Name	Generic Name
0054-9628	N/A	sodium oxybate
0517-0920	N/A	busulfan
43386-405	N/A	nitazoxanide
58443-0318	Austalian Gold	n/a
0409-1112	BUSULFAN	BUSULFAN
16729-351	Busulfan	busulfan
25021-241	Busulfan	Busulfan
45963-640	Busulfan	Busulfan
51817-170	Busulfan	busulfan
59148-047	BUSULFEX	busulfan
59148-070	BUSULFEX	busulfan
50241-028	D7 Decon Seven	N/A
50241-154	E3 Foaming Hand Sanitizer	N/A
50241-986	E3 Foaming Hand Sanitizer	N/A
50241-985	Healthy Hands Foaming Hand Sanitizer	N/A
50241-014	MG DermaClean	N/A
50241-259	MG DermaSan	N/A
50241-030	MG DermaWash	N/A
50241-333	SONO HEALTHCARE	N/A