Home NDC 45963-614-85 Irinotecan hydrochloride
Product NDC 45963-614
Requested package NDC 45963-614-85
11-digit product format 459630614
Labeler code 45963
Product ID 45963-614_3bbdb61c-9194-416e-9034-5d2b11b5b8ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irinotecan hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Actavis Pharma, Inc.
Application ANDA078589
Marketing category ANDA
Marketing start 2015-03-12
Marketing end 2027-09-30
Substance IRINOTECAN HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A078589-001 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 A078589-002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 A078589-003 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18
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 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726319 Internal RxNorm lookup 1726324 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 45963-614-51 Irinotecan hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 27 45963-614-51 Irinotecan hydrochloride 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 27 45963-614-55 Irinotecan hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 27 45963-614-55 Irinotecan hydrochloride 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IRINOTECAN HYDROCHLORIDE ACTIVE INGREDIENT 042LAQ1IIS IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 9 IRINOTECAN ACTIVE MOIETY 7673326042 IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 9 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 9 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 9 SORBITOL INACTIVE INGREDIENT 506T60A25R IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-614 IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 25 Current NDC, Legacy NDC, 4 package rows 20230610_5e1fdcaa-918f-4cd8-9c7a-4c538d866198.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 · 1 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 45963-614-85 45963061485 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-85) > 5 mL in 1 VIAL, SINGLE-DOSE 2018-08-10 0000-00-00 No No Current