Home NDC 67184-0513 Irinotecan Hydrochloride
Product NDC 67184-0513
11-digit product format 671840513
Labeler code 67184
Product ID 67184-0513_5faaf9ca-ed20-4ebf-9e7f-1d3a0ca60056
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irinotecan Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Qilu Pharmaceutical Co., Ltd.
Application ANDA203380
Marketing category ANDA
Marketing start 2016-05-03
Substance IRINOTECAN HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203380-001 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 A203380-002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 A203380-003 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203380-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203380-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203380-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2016-05-03 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Irinotecan Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IRINOTECAN HYDROCHLORIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 042LAQ1IIS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726319 Internal RxNorm lookup 1726324 Internal RxNorm lookup 1726333 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67184-0513-1 Irinotecan Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 5 67184-0513-1 Irinotecan Hydrochloride 15 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 15 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67184-0513 IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] 5 Current NDC, Legacy NDC, 2 package rows 20210311_afcdde49-ec0c-4c56-a1af-2917185b1a08.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67184-0513-1 67184051301 1 VIAL, SINGLE-USE in 1 CARTON (67184-0513-1) / 15 mL in 1 VIAL, SINGLE-USE 2016-05-03 0000-00-00 No No Current