irinotecan hydrochloride

Generic: irinotecan hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irinotecan hydrochloride
Generic Name irinotecan hydrochloride
Labeler northstar rx llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 20 mg/mL

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-027
Product ID 16714-027_7d7ed052-95ae-6d58-f41f-ada9f8f97b81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212993
Listing Expiration 2026-12-31
Marketing Start 2020-11-15

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714027
Hyphenated Format 16714-027

Supplemental Identifiers

RxCUI
1726319 1726324
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 hydrochloride (source: ndc)
Generic Name irinotecan hydrochloride (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 (16714-027-01) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

16714-027-01 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-027-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

irinotecan hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Irinotecan hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7d7ed052-95ae-6d58-f41f-ada9f8f97b81", "openfda": {"unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726324"], "spl_set_id": ["4f98e9ed-f7b1-5346-af72-fccb0abf3f4b"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (16714-027-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "16714-027-01", "marketing_start_date": "20201115"}], "brand_name": "Irinotecan hydrochloride", "product_id": "16714-027_7d7ed052-95ae-6d58-f41f-ada9f8f97b81", "dosage_form": "INJECTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "16714-027", "generic_name": "Irinotecan hydrochloride", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan hydrochloride", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA212993", "marketing_category": "ANDA", "marketing_start_date": "20201115", "listing_expiration_date": "20261231"}