FDA.reportPublic FDA data

Irinotecan hydrochloride

Product NDC
45963-614
11-digit product format
459630614
Labeler code
45963
Product ID
45963-614_3bbdb61c-9194-416e-9034-5d2b11b5b8ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Actavis Pharma, Inc.
Application
ANDA078589
Marketing category
ANDA
Marketing start
2015-03-12
Marketing end
2027-09-30
Substance
IRINOTECAN HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45963-614DDiscontinued by firm2026-08-10
excluded packagepackage45963-61445963-614-81DDiscontinued by firm2026-08-10
excluded packagepackage45963-61445963-614-85DDiscontinued by firm2026-08-10

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 · 36 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 packagepackage45963-614-85d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45963-614-81d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45963-614-85f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45963-614-81f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45963-614-852ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45963-614-812ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45963-614-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45963-614-81a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45963-614-85cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45963-614-81cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45963-614-85cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45963-614-81cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45963-614-85302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45963-614-81302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45963-614-85ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45963-614-81ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45963-614-850efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45963-614-810efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45963-614-85ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45963-614-81ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45963-614-85367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45963-614-81367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45963-614-85557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45963-614-81557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078589-001IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27
A078589-002IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27
A078589-003IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078589-001AP
A078589-002AP
A078589-003AP

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078589-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078589-003IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAP2015-11-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078589-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078589-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078589-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078589-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078589-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078589-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078589-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078589-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078589-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078589-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078589-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078589-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078589-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078589-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078589-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078589-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078589-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078589-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078589-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078589-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078589-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078589-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078589-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078589-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078589-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078589-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078589-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078589-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078589-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078589-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078589-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078589-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078589-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078589-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078589-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078589-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078589-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078589-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078589-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078589-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078589-001AP18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Irinotecan hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRINOTECAN HYDROCHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
042LAQ1IISInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1726319Internal RxNorm lookup
1726324Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e1fdcaa-918f-4cd8-9c7a-4c538d866198Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45963-614-51Irinotecan hydrochloride1 in 1 CARTONINJECTION, SOLUTION127
45963-614-51Irinotecan hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION227
45963-614-55Irinotecan hydrochloride1 in 1 CARTONINJECTION, SOLUTION127
45963-614-55Irinotecan hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION527

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-614-51ML - Milliliter45963-61447ff70ea-1aae-4938-9a95-531a4f7c0a4f12015-02-02
45963-614-55ML - Milliliter45963-61459851ee2-68a4-43c3-a19c-d9863ed15ed212015-02-02
45963-614-81ML - Milliliter45963-6140fb6a7a5-645f-46eb-8cdc-277da62fffcd12019-02-13
45963-614-85ML - Milliliter45963-614e6853836-23a8-4d76-b493-f097c6cc32f412018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IRINOTECAN HYDROCHLORIDEACTIVE INGREDIENT042LAQ1IISIRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]9
IRINOTECANACTIVE MOIETY7673326042IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]9
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]9
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATIRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IIRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]9
SORBITOLINACTIVE INGREDIENT506T60A25RIRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-614IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]25Current NDC, Legacy NDC, 4 package rows20230610_5e1fdcaa-918f-4cd8-9c7a-4c538d866198.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Irinotecan hydrochlorideIRINOTECAN HYDROCHLORIDEActavis Pharma, Inc.5e1fdcaa-918f-4cd8-9c7a-4c538d8661982025-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078589
application number: ANDA078589
ndc (product): 45963-614

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSN5e1fdcaa-918f-4cd8-9c7a-4c538d86619827
1726319irinotecan HCl 40 MG in 2 ML InjectionPSN5e1fdcaa-918f-4cd8-9c7a-4c538d86619827
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCD5e1fdcaa-918f-4cd8-9c7a-4c538d86619827
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCD5e1fdcaa-918f-4cd8-9c7a-4c538d86619827
1726324irinotecan HCl 100 MG per 5 ML InjectionSY5e1fdcaa-918f-4cd8-9c7a-4c538d86619827
1726319irinotecan HCl 40 MG per 2 ML InjectionSY5e1fdcaa-918f-4cd8-9c7a-4c538d86619827

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45963-614-51459630614511 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-51) / 2 mL in 1 VIAL, SINGLE-DOSE2015-03-122027-09-30NoNoCurrent
45963-614-55459630614551 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-55) / 5 mL in 1 VIAL, SINGLE-DOSE2015-03-122027-09-30NoNoCurrent
45963-614-81459630614811 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-81) > 2 mL in 1 VIAL, SINGLE-DOSE2019-01-170000-00-00NoNoCurrent
45963-614-85459630614851 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-85) > 5 mL in 1 VIAL, SINGLE-DOSE2018-08-100000-00-00NoNoCurrent