Irinotecan Hydrochloride

Product NDC: 72485-213
11-digit product format: 724850213
Labeler code: 72485
Product ID: 72485-213_16bc41f7-c83f-473e-bf17-9e6328cecb4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irinotecan Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA208718
Marketing category: ANDA
Marketing start: 2020-09-04
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72485-213		D	Discontinued by firm		2026-08-11
excluded package	package	72485-213	72485-213-15	D	Discontinued by firm		2026-08-11

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208718-001	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28
A208718-002	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28
A208718-003	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208718-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208718-003	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208718-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2018-12-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208718-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208718-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208718-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208718-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208718-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208718-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208718-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208718-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208718-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208718-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208718-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208718-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208718-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208718-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208718-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208718-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208718-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208718-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208718-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208718-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208718-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208718-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208718-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208718-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208718-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208718-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208718-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208718-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208718-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208718-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208718-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208718-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208718-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208718-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208718-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208718-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208718-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208718-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208718-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208718-001	AP	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cfce77d6-e90b-6280-14b8-e6a66a38ebbc	Product name	7	20210525
077454e2-2db8-411c-801d-08d70e0bebab	Product name	1	20151116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72485-213-15	Irinotecan Hydrochloride	1 in 1 CARTON	INJECTION	1		1
72485-213-15	Irinotecan Hydrochloride	15 mL in 1 VIAL, SINGLE-DOSE	INJECTION	15		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72485-213	IRINOTECAN HYDROCHLORIDE INJECTION [ARMAS PHARMACEUTICALS INC.]	1	Current NDC, Legacy NDC, 2 package rows	20200908_6a186e60-6ea1-4450-9668-dac7dd7a03e3.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
1726333	irinotecan HCl 300 MG in 15 ML Injection	PSN	6a186e60-6ea1-4450-9668-dac7dd7a03e3	1
1726333	15 ML irinotecan hydrochloride 20 MG/ML Injection	SCD	6a186e60-6ea1-4450-9668-dac7dd7a03e3	1
1726333	irinotecan HCl 300 MG per 15 ML Injection	SY	6a186e60-6ea1-4450-9668-dac7dd7a03e3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72485-213-15	72485021315	1 VIAL, SINGLE-DOSE in 1 CARTON (72485-213-15) / 15 mL in 1 VIAL, SINGLE-DOSE	2020-09-04	0000-00-00	No	No	Current