NDC 68083-381

Irinotecan hydrochloide

Irinotecan Hydrochloide

Irinotecan hydrochloide is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Irinotecan Hydrochloride.

• Product ID: 68083-381_a1ced9af-9117-485c-925d-47f7266bc9df
• NDC: 68083-381
• Product Type: Human Prescription Drug
• Proprietary Name: Irinotecan hydrochloide
• Generic Name: Irinotecan Hydrochloide
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-11-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA212993
• Labeler Name: Gland Pharma Limited
• Substance Name: IRINOTECAN HYDROCHLORIDE
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 68083-381-01

1 VIAL, SINGLE-DOSE in 1 CARTON (68083-381-01) > 2 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-11-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-381-01 [68083038101]

Irinotecan hydrochloide INJECTION

• Marketing Category: ANDA
• Application Number: ANDA212993
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-11-18

Drug Details

Active Ingredients

Ingredient	Strength
IRINOTECAN HYDROCHLORIDE	20 mg/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Irinotecan hydrochloide" or generic name "Irinotecan Hydrochloide"

NDC	Brand Name	Generic Name
68001-480	Irinotecan hydrochloide	Irinotecan hydrochloide
68083-381	Irinotecan hydrochloide	Irinotecan hydrochloide
70700-169	Irinotecan hydrochloide	Irinotecan hydrochloide