Home NDC 55150-354 IRINOTECAN HYDROCHLORIDE
Product NDC 55150-354
11-digit product format 551500354
Labeler code 55150
Product ID 55150-354_2fc24d11-bf17-4007-8a65-d949793a972e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IRINOTECAN HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA213278
Marketing category ANDA
Marketing start 2020-02-11
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213278-001 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 A213278-002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 A213278-003 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 A213278-004 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 · 137 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 A213278-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213278-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213278-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213278-004 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213278-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213278-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213278-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213278-004 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213278-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213278-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213278-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213278-004 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213278-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213278-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213278-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213278-004 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213278-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213278-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213278-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213278-004 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213278-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213278-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213278-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213278-004 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213278-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213278-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213278-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213278-004 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213278-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213278-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213278-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213278-004 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213278-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213278-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213278-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213278-004 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213278-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213278-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213278-003 IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE / INJECTION AP 2020-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213278-004 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2022-04-11 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 137 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 55150-354-01 IRINOTECAN HYDROCHLORIDE 15 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 15 4 55150-354-01 IRINOTECAN HYDROCHLORIDE 1 in 1 CARTON INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-354 IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC] 3 Current NDC, Legacy NDC, 2 package rows 20230731_7a30d551-9ea7-47ea-9073-f541bff457a3.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 55150-354-01 55150035401 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-354-01) / 15 mL in 1 VIAL, SINGLE-DOSE 2020-02-11 0000-00-00 No No Current