NDC 68083-382

Irinotecan hydrochloride

Irinotecan Hydrochloride

Irinotecan hydrochloride 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 ID68083-382_a1ced9af-9117-485c-925d-47f7266bc9df
NDC68083-382
Product TypeHuman Prescription Drug
Proprietary NameIrinotecan hydrochloride
Generic NameIrinotecan Hydrochloride
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 68083-382-01

1 VIAL, SINGLE-DOSE in 1 CARTON (68083-382-01) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-382-01 [68083038201]

Irinotecan hydrochloride 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 hydrochloride" or generic name "Irinotecan Hydrochloride"

NDCBrand NameGeneric Name
0143-9583Irinotecan HydrochlorideIrinotecan Hydrochloride
0143-9701Irinotecan HydrochlorideIrinotecan Hydrochloride
0143-9702Irinotecan HydrochlorideIrinotecan Hydrochloride
0703-4432Irinotecan HydrochlorideIrinotecan Hydrochloride
0703-4434Irinotecan HydrochlorideIrinotecan Hydrochloride
16714-027Irinotecan hydrochlorideIrinotecan hydrochloride
16714-131Irinotecan hydrochlorideIrinotecan hydrochloride
16714-725Irinotecan HydrochlorideIrinotecan Hydrochloride
16714-726Irinotecan HydrochlorideIrinotecan Hydrochloride
23155-179Irinotecan HydrochlorideIrinotecan Hydrochloride
25021-230Irinotecan Hydrochlorideirinotecan hydrochloride
45963-614Irinotecan hydrochlorideIrinotecan hydrochloride
50742-401Irinotecan HydrochlorideIrinotecan Hydrochloride
68001-284Irinotecan HydrochlorideIrinotecan Hydrochloride
50742-402Irinotecan HydrochlorideIrinotecan Hydrochloride
59923-714Irinotecan HydrochlorideIrinotecan Hydrochloride
59923-702Irinotecan HydrochlorideIrinotecan Hydrochloride
60505-6128Irinotecan HydrochlorideIrinotecan Hydrochloride
59923-715Irinotecan HydrochlorideIrinotecan Hydrochloride
61703-349Irinotecan HydrochlorideIrinotecan Hydrochloride
63323-193Irinotecan HydrochlorideIrinotecan Hydrochloride
67184-0513Irinotecan HydrochlorideIrinotecan Hydrochloride
67184-0512Irinotecan HydrochlorideIrinotecan Hydrochloride
67184-0511Irinotecan HydrochlorideIrinotecan Hydrochloride
68083-382Irinotecan hydrochlorideIrinotecan hydrochloride
59923-716Irinotecan HydrochlorideIrinotecan Hydrochloride
0009-1111Camptosaririnotecan hydrochloride
0009-7529Camptosaririnotecan hydrochloride
15054-0043OnivydeIRINOTECAN HYDROCHLORIDE
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