NDC 63323-104

Etoposide

Etoposide

Etoposide is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Etoposide.

• Product ID: 63323-104_9b008181-ab92-db2f-e053-2995a90aad57
• NDC: 63323-104
• Product Type: Human Prescription Drug
• Proprietary Name: Etoposide
• Generic Name: Etoposide
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2001-07-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074983
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: ETOPOSIDE
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63323-104-05

10 BOX in 1 CARTON (63323-104-05) > 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01) > 5 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2001-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-104-05 [63323010405]

Etoposide INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074983
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-07-18

NDC 63323-104-01 [63323010401]

Etoposide INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074983
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-06-11

NDC 63323-104-50 [63323010450]

Etoposide INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074983
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-07-18

NDC 63323-104-25 [63323010425]

Etoposide INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074983
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-07-18

Drug Details

Active Ingredients

Ingredient	Strength
ETOPOSIDE	20 mg/mL

OpenFDA Data

• SPL SET ID: fe870629-104d-4d67-a7c6-f53bc588121e
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 6PLQ3CP4P3
• RxNorm Concept Unique ID - RxCUI:
  • 310248

Pharmacological Class

• Topoisomerase Inhibitor [EPC]
• Topoisomerase Inhibitors [MoA]

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

NDC	Brand Name	Generic Name
0143-9376	Etoposide	Etoposide
0143-9510	Etoposide	Etoposide
0143-9511	Etoposide	Etoposide
0143-9512	Etoposide	Etoposide
0378-3266	Etoposide	etoposide
16729-114	Etoposide	Etoposide
16729-262	Etoposide	Etoposide
63323-104	Etoposide	ETOPOSIDE
68001-265	Etoposide	Etoposide
0703-5653	Toposar	Etoposide
0703-5656	Toposar	Etoposide
0703-5657	Toposar	Etoposide