Home NDC 68001-480 Irinotecan hydrochloide
Product NDC 68001-480
11-digit product format 680010480
Labeler code 68001
Product ID 68001-480_30b09e30-01bd-efc4-e063-6394a90aabc3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irinotecan hydrochloide
Dosage form INJECTION
Route INTRAVENOUS
Labeler BluePoint Laboratories
Application ANDA212993
Marketing category ANDA
Marketing start 2020-12-14
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212993-001 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 A212993-002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18
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 2 · 76 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 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212993-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212993-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2019-11-18 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Irinotecan hydrochloide
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 68001-480-22 Irinotecan hydrochloide 1 in 1 CARTON INJECTION 1 7 68001-480-22 Irinotecan hydrochloide 5 mL in 1 VIAL, SINGLE-DOSE INJECTION 5 7 68001-480-35 Irinotecan hydrochloide 1 in 1 CARTON INJECTION 1 7 68001-480-35 Irinotecan hydrochloide 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-480 IRINOTECAN HYDROCHLOIDE INJECTION [BLUEPOINT LABORATORIES] 7 Current NDC, Legacy NDC, 4 package rows 20250322_b66dbd6d-6ccb-ce9d-e053-2995a90a4c3c.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Irinotecan hydrochloide IRINOTECAN HYDROCHLOIDE Xiromed LLC b26e5d27-dba5-7538-9e7b-48b358998cbb 2026-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212993 application number: ANDA212993 Irinotecan hydrochloide IRINOTECAN HYDROCHLOIDE BluePoint Laboratories b66dbd6d-6ccb-ce9d-e053-2995a90a4c3c 2025-03-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212993 application number: ANDA212993 ndc (product): 68001-480 Irinotecan hydrochloride IRINOTECAN HYDROCHLORIDE Northstar Rx LLC 4f98e9ed-f7b1-5346-af72-fccb0abf3f4b 2022-03-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212993 application number: ANDA212993 Irinotecan hydrochloide IRINOTECAN HYDROCHLOIDE Gland Pharma Limited de634e80-328a-4473-b395-0172683a2411 2022-03-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212993 application number: ANDA212993
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 68001-480-22 68001048022 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-22) / 5 mL in 1 VIAL, SINGLE-DOSE 2020-12-14 0000-00-00 No No Current 68001-480-35 68001048035 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-35) / 2 mL in 1 VIAL, SINGLE-DOSE 2020-12-14 0000-00-00 No No Current