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 ID68083-381_a1ced9af-9117-485c-925d-47f7266bc9df
NDC68083-381
Product TypeHuman Prescription Drug
Proprietary NameIrinotecan hydrochloide
Generic NameIrinotecan Hydrochloide
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-11-18
Marketing CategoryANDA / ANDA
Application NumberANDA212993
Labeler NameGland Pharma Limited
Substance NameIRINOTECAN HYDROCHLORIDE
Active Ingredient Strength20 mg/mL
Pharm ClassesTopoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68083-381-01

1 VIAL, SINGLE-DOSE in 1 CARTON (68083-381-01) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-381-01 [68083038101]

Irinotecan hydrochloide INJECTION
Marketing CategoryANDA
Application NumberANDA212993
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-18

Drug Details

Active Ingredients

IngredientStrength
IRINOTECAN HYDROCHLORIDE20 mg/mL

Pharmacological Class

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

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

NDCBrand NameGeneric Name
68001-480Irinotecan hydrochloideIrinotecan hydrochloide
68083-381Irinotecan hydrochloideIrinotecan hydrochloide
70700-169Irinotecan hydrochloideIrinotecan hydrochloide
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