Home NDC 59923-702 Irinotecan Hydrochloride
Product NDC 59923-702
11-digit product format 599230702
Labeler code 59923
Product ID 59923-702_861da8ed-500e-4495-e053-2a91aa0ac4d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irinotecan Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Areva Pharmaceuticals,Inc.
Application ANDA077219
Marketing category ANDA
Marketing start 2008-02-20
Marketing end 0000-00-00
Substance IRINOTECAN HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077219-001 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 A077219-002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20
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 3 · 82 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 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077219-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077219-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-20 782e0a99824c…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 59923-702-02 2025-12-30 These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE injection, USP safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE injection, USP. IRINOTECAN HYDROCHLORIDE injection USP, intravenous infusion Initial U.S. Approval: 1996 59923-702-05 2025-12-30 These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE injection, USP safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE injection, USP. IRINOTECAN HYDROCHLORIDE injection USP, intravenous infusion Initial U.S. Approval: 1996 59923-702-02 2024-01-30 These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE injection, USP safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE injection, USP. IRINOTECAN HYDROCHLORIDE injection USP, intravenous infusion Initial U.S. Approval: 1996 59923-702-05 2024-01-30 These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE injection, USP safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE injection, USP. IRINOTECAN HYDROCHLORIDE injection USP, intravenous infusion Initial U.S. Approval: 1996
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59923-702 IRINOTECAN HYDROCHLORIDE INJECTION [AREVA PHARMACEUTICALS,INC.] 7 Legacy NDC 20190410_80f3b79c-a399-45b3-b755-8535457719af.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59923-702-02 59923070202 1 VIAL in 1 CARTON (59923-702-02) > 2 mL in 1 VIAL 1 vial 2008-02-20 0000-00-00 No No Current 59923-702-05 59923070205 1 VIAL in 1 CARTON (59923-702-05) > 5 mL in 1 VIAL 1 vial 2008-02-20 0000-00-00 No No Current