Home NDC 0703-4432 Irinotecan Hydrochloride
Product NDC 0703-4432
11-digit product format 007034432
Labeler code 0703
Product ID 0703-4432_44fdc8cc-0d13-4b49-b79d-81bbb93c67c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irinotecan Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA090101
Marketing category ANDA
Marketing start 2008-02-28
Marketing end 2019-11-30
Substance IRINOTECAN HYDROCHLORIDE
Active strength 40 mg/2mL
Pharmacologic classes Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0703-4432-81 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0703-4432-11 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0703-4432-81 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0703-4432-11 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0703-4432-81 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0703-4432-11 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0703-4432-81 a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0703-4432-11 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0703-4432-81 cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0703-4432-11 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0703-4432-81 cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0703-4432-11 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0703-4432-81 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0703-4432-11 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0703-4432-81 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0703-4432-11 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0703-4432-81 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0703-4432-11 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0703-4432-81 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0703-4432-11 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0703-4432-81 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0703-4432-11 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0703-4432-81 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0703-4432-11 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 A090101-001 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 A090101-002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 A090101-003 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090101-001 AP
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 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090101-002 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090101-003 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION 2008-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090101-001 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2008-11-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 75 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IRINOTECAN HYDROCHLORIDE ACTIVE INGREDIENT 042LAQ1IIS IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 9 IRINOTECAN ACTIVE MOIETY 7673326042 IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 9 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 9 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 9 SORBITOL INACTIVE INGREDIENT 506T60A25R IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 9 WATER INACTIVE INGREDIENT 059QF0KO0R IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 9