FDA.reportPublic FDA data

Irinotecan Hydrochloride

Product NDC
63323-193
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

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 productproduct63323-193DDiscontinued by firm2026-08-11
excluded packagepackage63323-19363323-193-02DDiscontinued by firm2026-08-11
excluded packagepackage63323-19363323-193-05DDiscontinued by firm2026-08-11

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 · 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 packagepackage63323-193-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63323-193-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63323-193-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63323-193-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63323-193-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63323-193-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63323-193-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63323-193-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63323-193-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63323-193-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63323-193-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63323-193-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63323-193-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63323-193-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63323-193-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63323-193-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63323-193-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63323-193-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63323-193-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63323-193-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63323-193-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63323-193-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63323-193-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63323-193-05557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077776-001IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27
A077776-002IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077776-001AP
A077776-002AP

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077776-001IRINOTECAN HYDROCHLORIDE40MG/2ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A077776-002IRINOTECAN HYDROCHLORIDE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONAP2008-02-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077776-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077776-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077776-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077776-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077776-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077776-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077776-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077776-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077776-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077776-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077776-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077776-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077776-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077776-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077776-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077776-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077776-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077776-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077776-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077776-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077776-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077776-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077776-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077776-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077776-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077776-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077776-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077776-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077776-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077776-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077776-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077776-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077776-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077776-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077776-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077776-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077776-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077776-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077776-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077776-002AP1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Irinotecan Hydrochloride
Listing expiration
2026-12-31

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
ee45f127-8450-4455-a945-a1f5707f1d39Available 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
63323-193-52Irinotecan Hydrochloride1 in 1 BOXINJECTION, SOLUTION17
63323-193-52Irinotecan Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION27
63323-193-55Irinotecan Hydrochloride1 in 1 BOXINJECTION, SOLUTION17
63323-193-55Irinotecan Hydrochloride5 mL in 1 VIALINJECTION, SOLUTION57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-193-02ML - Milliliter63323-1930d2a9612-1068-424a-ad6c-f7db1ba72b8112012-07-24
63323-193-05ML - Milliliter63323-193a4ebbd96-794e-4ea2-9a9c-8b207c0eee0312012-07-24
63323-193-52ML - Milliliter63323-19338745ed2-b276-466c-812f-bd6419ab815112015-09-10
63323-193-55ML - Milliliter63323-193815ec171-6184-4ea8-95cc-0beea4b7a65412015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Irinotecan HydrochlorideACTIVE INGREDIENT042LAQ1IISIRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]6
IrinotecanACTIVE MOIETY7673326042IRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]6
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATIRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IIRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]6
SORBITOLINACTIVE INGREDIENT506T60A25RIRINOTECAN HYDROCHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]6
IRINOTECAN HYDROCHLORIDEACTIVE INGREDIENT042LAQ1IISIRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
IRINOTECANACTIVE MOIETY7673326042IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATIRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IIRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RIRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-193IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 4 package rows20230412_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEFresenius Kabi USA, LLCee45f127-8450-4455-a945-a1f5707f1d392023-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077776
application number: ANDA077776
ndc (product): 63323-193

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSNee45f127-8450-4455-a945-a1f5707f1d397
1726319irinotecan HCl 40 MG in 2 ML InjectionPSNee45f127-8450-4455-a945-a1f5707f1d397
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCDee45f127-8450-4455-a945-a1f5707f1d397
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCDee45f127-8450-4455-a945-a1f5707f1d397
1726324irinotecan HCl 100 MG per 5 ML InjectionSYee45f127-8450-4455-a945-a1f5707f1d397
1726319irinotecan HCl 40 MG per 2 ML InjectionSYee45f127-8450-4455-a945-a1f5707f1d397

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-193-52633230193521 VIAL in 1 BOX (63323-193-52) / 2 mL in 1 VIAL1 vial2009-04-010000-00-00NoNoCurrent
63323-193-55633230193551 VIAL in 1 BOX (63323-193-55) / 5 mL in 1 VIAL1 vial2009-04-010000-00-00NoNoCurrent