Home NDC 63323-193-55 Irinotecan Hydrochloride
Product NDC 63323-193
Requested package NDC 63323-193-55
11-digit product format 633230193
Labeler code 63323
Product ID 63323-193_4e0a18c8-35aa-447c-bd91-b81d7d494d8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IRINOTECAN HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA077776
Marketing category ANDA
Marketing start 2009-04-01
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 43 .
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 A077776-001 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 A077776-002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 2026-09-14 22:38:34 2026-08 A077776-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077776-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077776-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077776-001 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 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077776-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077776-001 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 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077776-001 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 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077776-001 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 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077776-001 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 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077776-001 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 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077776-001 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 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077776-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077776-001 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 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077776-001 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 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077776-001 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 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077776-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077776-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077776-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077776-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077776-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077776-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 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 63323-193-52 Irinotecan Hydrochloride 1 in 1 BOX INJECTION, SOLUTION 1 7 63323-193-52 Irinotecan Hydrochloride 2 mL in 1 VIAL INJECTION, SOLUTION 2 7 63323-193-55 Irinotecan Hydrochloride 1 in 1 BOX INJECTION, SOLUTION 1 7 63323-193-55 Irinotecan Hydrochloride 5 mL in 1 VIAL INJECTION, SOLUTION 5 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Irinotecan Hydrochloride ACTIVE INGREDIENT 042LAQ1IIS IRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC] 6 Irinotecan ACTIVE MOIETY 7673326042 IRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC] 6 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT IRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC] 6 SORBITOL INACTIVE INGREDIENT 506T60A25R IRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC] 6 IRINOTECAN HYDROCHLORIDE ACTIVE INGREDIENT 042LAQ1IIS IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 IRINOTECAN ACTIVE MOIETY 7673326042 IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-193 IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 7 Current NDC, Legacy NDC, 4 package rows 20230412_ee45f127-8450-4455-a945-a1f5707f1d39.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 Units Marketing start Marketing end Sample Exclude flag Status 63323-193-55 63323019355 1 VIAL in 1 BOX (63323-193-55) / 5 mL in 1 VIAL 1 vial 2009-04-01 0000-00-00 No No Current