Irinotecan Hydrochloride

Product NDC: 25021-230
11-digit product format: 250210230
Labeler code: 25021
Product ID: 25021-230_34acdbd5-5ca7-485d-8cfe-06c58e5f54d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: irinotecan hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA090675
Marketing category: ANDA
Marketing start: 2014-08-15
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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	25021-230		D	Discontinued by firm	2026-11-06
excluded package	package	25021-230	25021-230-02	D	Discontinued by firm	2026-11-06
excluded package	package	25021-230	25021-230-05	D	Discontinued by firm	2026-11-06

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090675-001	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION			2011-12-16
A090675-002	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION			2011-12-16

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2011-12-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2011-12-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2011-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2011-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2011-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2011-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2011-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2011-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION		2011-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION		2011-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090675-001	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090675-002	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2011-12-16	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A090675-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090675-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090675-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090675-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090675-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090675-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090675-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090675-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090675-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090675-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090675-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090675-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090675-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090675-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090675-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090675-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090675-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090675-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090675-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090675-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090675-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090675-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090675-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090675-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090675-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090675-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090675-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090675-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090675-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090675-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090675-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090675-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090675-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090675-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090675-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090675-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090675-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090675-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090675-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090675-002	AP	1	`5aa47cf7b7d7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cfce77d6-e90b-6280-14b8-e6a66a38ebbc	Product name	7	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
077454e2-2db8-411c-801d-08d70e0bebab	Product name	1	20151116
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
25021-230-02	Irinotecan Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1	12
25021-230-02	Irinotecan Hydrochloride	2 mL in 1 VIAL	INJECTION, SOLUTION	2	12
25021-230-05	Irinotecan Hydrochloride	5 mL in 1 VIAL	INJECTION, SOLUTION	5	12
25021-230-05	Irinotecan Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-230-02	ML - Milliliter	25021-230	c047ca02-a722-452f-adf4-92fbf9f3cd5c	1	2014-07-02
25021-230-05	ML - Milliliter	25021-230	c4aa62a4-7f46-4027-9f4d-d79d346ec79e	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
irinotecan hydrochloride	ACTIVE INGREDIENT	042LAQ1IIS	IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
irinotecan	ACTIVE MOIETY	7673326042	IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
lactic acid	INACTIVE INGREDIENT	33X04XA5AT	IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4
sorbitol	INACTIVE INGREDIENT	506T60A25R	IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-230	IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	11	Legacy NDC, 4 package rows	20250212_caab50e6-0dad-4ddd-9a6c-96cc2b87aee7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
042LAQ1IIS	IRINOTECAN HYDROCHLORIDE	136572-09-3	IRINOTECAN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1726324	irinotecan HCl 100 MG in 5 ML Injection	PSN	caab50e6-0dad-4ddd-9a6c-96cc2b87aee7	12
1726319	irinotecan HCl 40 MG in 2 ML Injection	PSN	caab50e6-0dad-4ddd-9a6c-96cc2b87aee7	12
1726319	2 ML irinotecan hydrochloride 20 MG/ML Injection	SCD	caab50e6-0dad-4ddd-9a6c-96cc2b87aee7	12
1726324	5 ML irinotecan hydrochloride 20 MG/ML Injection	SCD	caab50e6-0dad-4ddd-9a6c-96cc2b87aee7	12
1726324	irinotecan HCl 100 MG per 5 ML Injection	SY	caab50e6-0dad-4ddd-9a6c-96cc2b87aee7	12
1726319	irinotecan HCl 40 MG per 2 ML Injection	SY	caab50e6-0dad-4ddd-9a6c-96cc2b87aee7	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-230-02	25021023002	1 VIAL in 1 CARTON (25021-230-02) > 2 mL in 1 VIAL	1 vial	2014-08-15	0000-00-00	No	No	Current
25021-230-05	25021023005	1 VIAL in 1 CARTON (25021-230-05) > 5 mL in 1 VIAL	1 vial	2014-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Irinotecan Hydrochloride	Sagent Pharmaceuticals \| Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	12