Irinotecan hydrochloide

Product NDC: 68083-381
Requested package NDC: 68083-381-01
11-digit product format: 680830381
Labeler code: 68083
Product ID: 68083-381_a1ced9af-9117-485c-925d-47f7266bc9df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irinotecan hydrochloide
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA212993
Marketing category: ANDA
Marketing start: 2019-11-18
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

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212993-001	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-11-18
A212993-002	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP		2019-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212993-001	AP
A212993-002	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 2 · 76 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	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212993-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212993-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2019-11-18	`87673890dc5c…`

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
2026-02-19 14:30 UTC	2026-02	A212993-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212993-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212993-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212993-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212993-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212993-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212993-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212993-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212993-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212993-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212993-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212993-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212993-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212993-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212993-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212993-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212993-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212993-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212993-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212993-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212993-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212993-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212993-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212993-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212993-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212993-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212993-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212993-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212993-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212993-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212993-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212993-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212993-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212993-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212993-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212993-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212993-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212993-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212993-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212993-002	AP	1	`87673890dc5c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IRINOTECAN HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
042LAQ1IIS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
de634e80-328a-4473-b395-0172683a2411	Available on FDA.report

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	Strength	SPL version
68083-381-01	Irinotecan hydrochloide	1 in 1 CARTON	INJECTION	1		10
68083-381-01	Irinotecan hydrochloide	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-381	IRINOTECAN HYDROCHLOIDE INJECTION IRINOTECAN HYDROCHLORIDE INJECTION [GLAND PHARMA LIMITED]	10	Current NDC, Legacy NDC, 2 package rows	20220304_de634e80-328a-4473-b395-0172683a2411.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irinotecan hydrochloide	IRINOTECAN HYDROCHLOIDE	Xiromed LLC	b26e5d27-dba5-7538-9e7b-48b358998cbb	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212993 application number: ANDA212993
Irinotecan hydrochloide	IRINOTECAN HYDROCHLOIDE	BluePoint Laboratories	b66dbd6d-6ccb-ce9d-e053-2995a90a4c3c	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212993 application number: ANDA212993
Irinotecan hydrochloride	IRINOTECAN HYDROCHLORIDE	Northstar Rx LLC	4f98e9ed-f7b1-5346-af72-fccb0abf3f4b	2022-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212993 application number: ANDA212993
Irinotecan hydrochloide	IRINOTECAN HYDROCHLOIDE	Gland Pharma Limited	de634e80-328a-4473-b395-0172683a2411	2022-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212993 application number: ANDA212993 ndc (package): 68083-381-01 ndc (product): 68083-381 ndc11 (package): 68083038101

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	de634e80-328a-4473-b395-0172683a2411	10
1726319	irinotecan HCl 40 MG in 2 ML Injection	PSN	de634e80-328a-4473-b395-0172683a2411	10
1726319	2 ML irinotecan hydrochloride 20 MG/ML Injection	SCD	de634e80-328a-4473-b395-0172683a2411	10
1726324	5 ML irinotecan hydrochloride 20 MG/ML Injection	SCD	de634e80-328a-4473-b395-0172683a2411	10
1726324	irinotecan HCl 100 MG per 5 ML Injection	SY	de634e80-328a-4473-b395-0172683a2411	10
1726319	irinotecan HCl 40 MG per 2 ML Injection	SY	de634e80-328a-4473-b395-0172683a2411	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-381-01	68083038101	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-381-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2019-11-18	0000-00-00	No	No	Current