irinotecan hydrochloide

Generic: irinotecan hydrochloide

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irinotecan hydrochloide
Generic Name irinotecan hydrochloide
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 20 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-381
Product ID 68083-381_a1ced9af-9117-485c-925d-47f7266bc9df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212993
Listing Expiration 2026-12-31
Marketing Start 2019-11-18

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083381
Hyphenated Format 68083-381

Supplemental Identifiers

RxCUI
1726319 1726324
UPC
0336808338107 0368083382018
UNII
042LAQ1IIS

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name irinotecan hydrochloide (source: ndc)
Generic Name irinotecan hydrochloide (source: ndc)
Application Number ANDA212993 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-381-01) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

irinotecan hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Irinotecan hydrochloide, Irinotecan hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a1ced9af-9117-485c-925d-47f7266bc9df", "openfda": {"upc": ["0336808338107", "0368083382018"], "unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726324"], "spl_set_id": ["de634e80-328a-4473-b395-0172683a2411"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-381-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-381-01", "marketing_start_date": "20191118"}], "brand_name": "Irinotecan hydrochloide", "product_id": "68083-381_a1ced9af-9117-485c-925d-47f7266bc9df", "dosage_form": "INJECTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "68083-381", "generic_name": "Irinotecan hydrochloide", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan hydrochloide", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA212993", "marketing_category": "ANDA", "marketing_start_date": "20191118", "listing_expiration_date": "20261231"}