Irinotecan Hydrochloride

Product NDC
59923-714
11-digit product format
599230714
Labeler code
59923
Product ID
59923-714_b8e4461e-df60-aa36-e053-2a95a90af916
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Areva Pharmaceuticals, Inc.
Application
ANDA208718
Marketing category
ANDA
Marketing start
2019-03-01
Marketing end
0000-00-00
Substance
IRINOTECAN HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59923-714IInactivated by FDA2026-08-11
excluded packagepackage59923-71459923-714-02IInactivated by FDA2026-08-11

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59923-714-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59923-714-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59923-714-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59923-714-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59923-714-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59923-714-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59923-714-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59923-714-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59923-714-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59923-714-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59923-714-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59923-714-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59923-714-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59923-714-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59923-714-021332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208718-001IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28
A208718-002IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28
A208718-003IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208718-001AP
A208718-002AP
A208718-003AP

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 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208718-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208718-003IRINOTECAN HYDROCHLORIDE300MG/15ML (20MG/ML)INJECTABLE / INJECTIONAP2019-08-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208718-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2018-12-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208718-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208718-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208718-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208718-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208718-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208718-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208718-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208718-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208718-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208718-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208718-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208718-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208718-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208718-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208718-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208718-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208718-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208718-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208718-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208718-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208718-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208718-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208718-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208718-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208718-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208718-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208718-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208718-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208718-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208718-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208718-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208718-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208718-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208718-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208718-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208718-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208718-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208718-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208718-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208718-001AP18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cfce77d6-e90b-6280-14b8-e6a66a38ebbcProduct name720210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
077454e2-2db8-411c-801d-08d70e0bebabProduct name120151116
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59923-714-02Irinotecan Hydrochloride2 mL in 1 VIALINJECTION25
59923-714-02Irinotecan Hydrochloride1 in 1 CARTONINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59923-714-02ML - Milliliter59923-714294276c2-262a-432f-aaff-8459d5ae377612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59923-714IRINOTECAN HYDROCHLORIDE INJECTION [AREVA PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20210115_82e95139-6222-f73d-e053-2a91aa0a4810.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSN82e95139-6222-f73d-e053-2a91aa0a48105
1726333irinotecan HCl 300 MG in 15 ML InjectionPSN82e95139-6222-f73d-e053-2a91aa0a48105
1726319irinotecan HCl 40 MG in 2 ML InjectionPSN82e95139-6222-f73d-e053-2a91aa0a48105
172633315 ML irinotecan hydrochloride 20 MG/ML InjectionSCD82e95139-6222-f73d-e053-2a91aa0a48105
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCD82e95139-6222-f73d-e053-2a91aa0a48105
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCD82e95139-6222-f73d-e053-2a91aa0a48105
1726324irinotecan HCl 100 MG per 5 ML InjectionSY82e95139-6222-f73d-e053-2a91aa0a48105
1726333irinotecan HCl 300 MG per 15 ML InjectionSY82e95139-6222-f73d-e053-2a91aa0a48105
1726319irinotecan HCl 40 MG per 2 ML InjectionSY82e95139-6222-f73d-e053-2a91aa0a48105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59923-714-02599230714021 VIAL in 1 CARTON (59923-714-02) > 2 mL in 1 VIAL1 vial2019-03-010000-00-00NoNoCurrent