NDC 16729-114

Etoposide

Etoposide

Etoposide is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is Etoposide.

• Product ID: 16729-114_5b5fb93c-86f2-b007-e053-2991aa0ad683
• NDC: 16729-114
• Product Type: Human Prescription Drug
• Proprietary Name: Etoposide
• Generic Name: Etoposide
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-03-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074513
• Labeler Name: Accord Healthcare Inc.
• 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 16729-114-08

1 VIAL, MULTI-DOSE in 1 BOX (16729-114-08) > 25 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2015-03-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16729-114-32 [16729011432]

Etoposide INJECTION

• Marketing Category: ANDA
• Application Number: ANDA074513
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-01

NDC 16729-114-08 [16729011408]

Etoposide INJECTION

• Marketing Category: ANDA
• Application Number: ANDA074513
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-03

NDC 16729-114-31 [16729011431]

Etoposide INJECTION

• Marketing Category: ANDA
• Application Number: ANDA074513
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-22

NDC 16729-114-11 [16729011411]

Etoposide INJECTION

• Marketing Category: ANDA
• Application Number: ANDA074513
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-03

Drug Details

Active Ingredients

Ingredient	Strength
ETOPOSIDE	20 mg/mL

OpenFDA Data

• SPL SET ID: 4f850eb2-3542-43a0-90e8-bb37fa05cf15
• Manufacturer:
  • Accord Healthcare Inc.
• UNII:
  • 6PLQ3CP4P3
• RxNorm Concept Unique ID - RxCUI:
  • 310248
• UPC Code:
  • 0316729114318
  • 0316729114110

Pharmacological Class

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