Camptosar

Product NDC: 0009-7529
Requested package NDC: 0009-7529-03
11-digit product format: 000097529
Labeler code: 0009
Product ID: 0009-7529_6f05fe24-191a-4273-ad62-4ab6b5324062
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: irinotecan hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA020571
Marketing category: NDA
Marketing start: 1996-06-14
Substance: IRINOTECAN HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0009-7529	0009-7529-03	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	RLD / RS	Approval date
N020571-001	CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14
N020571-002	CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14
N020571-003	CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020571-001	AP
N020571-002	AP
N020571-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N020571-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020571-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020571-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020571-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020571-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020571-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020571-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020571-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020571-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020571-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020571-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020571-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020571-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020571-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020571-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020571-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020571-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020571-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020571-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020571-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020571-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020571-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020571-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020571-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020571-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020571-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020571-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020571-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020571-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020571-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020571-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020571-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020571-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020571-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020571-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020571-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020571-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020571-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020571-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020571-001	AP	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020571-001	6403569	2020-04-28	U-449		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-001	6794370	2020-05-01	U-606		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-001	6403569*PED	2020-10-28		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-001	6794370*PED	2020-11-01		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-002	6403569	2020-04-28	U-449		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-002	6794370	2020-05-01	U-606		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-002	6403569*PED	2020-10-28		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-002	6794370*PED	2020-11-01		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020571-001	6403569	2020-04-28	U-449		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-001	6794370	2020-05-01	U-606		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-001	6403569*PED	2020-10-28		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-001	6794370*PED	2020-11-01		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-002	6403569	2020-04-28	U-449		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-002	6794370	2020-05-01	U-606		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-002	6403569*PED	2020-10-28		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-002	6794370*PED	2020-11-01		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020571-001	6403569	2020-04-28	U-449		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-001	6794370	2020-05-01	U-606		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-001	6403569*PED	2020-10-28		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-001	6794370*PED	2020-11-01		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-002	6403569	2020-04-28	U-449		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-002	6794370	2020-05-01	U-606		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-002	6403569*PED	2020-10-28		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-002	6794370*PED	2020-11-01		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020571-001	6403569	2020-04-28	U-449		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-001	6794370	2020-05-01	U-606		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-001	6403569*PED	2020-10-28		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-001	6794370*PED	2020-11-01		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-002	6403569	2020-04-28	U-449		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-002	6794370	2020-05-01	U-606		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-002	6403569*PED	2020-10-28		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-002	6794370*PED	2020-11-01		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020571-001	6403569	2020-04-28	U-449		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-001	6794370	2020-05-01	U-606		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-001	6403569*PED	2020-10-28		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-001	6794370*PED	2020-11-01		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-002	6403569	2020-04-28	U-449		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-002	6794370	2020-05-01	U-606		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-002	6403569*PED	2020-10-28		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-002	6794370*PED	2020-11-01		Pediatric extension	`b00525d2431f…`

Additional Listing Data#

Finished product: Yes
Brand name base: Camptosar
Listing expiration: 2027-12-31

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1726319	Internal RxNorm lookup
1726321	Internal RxNorm lookup
1726324	Internal RxNorm lookup
1726325	Internal RxNorm lookup
1726333	Internal RxNorm lookup
1726335	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
e518dfc6-7e93-4fee-a66c-51e1ab71c056	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
077454e2-2db8-411c-801d-08d70e0bebab	Product name	1	20151116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0009-7529-03	Camptosar	1 in 1 CARTON	INJECTION, SOLUTION	1	37
0009-7529-03	Camptosar	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5	37
0009-7529-04	Camptosar	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2	37
0009-7529-04	Camptosar	1 in 1 CARTON	INJECTION, SOLUTION	1	37
0009-7529-05	Camptosar	1 in 1 CARTON	INJECTION, SOLUTION	1	37
0009-7529-05	Camptosar	15 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	15	37
0009-7529-10	Camptosar	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2	37
0009-7529-10	Camptosar	1 in 1 CARTON	INJECTION, SOLUTION	1	37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-7529-03	ML - Milliliter	0009-7529	01770110-c380-4a58-ac0f-18cf1f9c1855	1	2012-07-24
0009-7529-04	ML - Milliliter	0009-7529	a32794a1-db8c-43a2-b84d-211b842f58b0	1	2012-07-24
0009-7529-05	ML - Milliliter	0009-7529	f4bb646b-5d8b-4119-8bcc-64dc877af7e6	1	2012-07-24
0009-7529-10	ML - Milliliter	0009-7529	d225ceaa-7e15-450b-8899-789d76bf8817	1	2025-01-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IRINOTECAN HYDROCHLORIDE	ACTIVE INGREDIENT	042LAQ1IIS	CAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	20
IRINOTECAN	ACTIVE MOIETY	7673326042	CAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	20
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	20
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	CAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	20
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-7529	CAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]	34	Current NDC, Legacy NDC, 8 package rows	20250101_e518dfc6-7e93-4fee-a66c-51e1ab71c056.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Camptosar	IRINOTECAN HYDROCHLORIDE	Pharmacia & Upjohn Company LLC	e518dfc6-7e93-4fee-a66c-51e1ab71c056	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020571 application number: NDA020571 ndc (package): 0009-7529-03 ndc (product): 0009-7529 ndc11 (package): 00009752903

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
1726325	Camptosar 100 MG in 5 ML Injection	PSN	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726335	Camptosar 300 MG in 15 ML Injection	PSN	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726321	Camptosar 40 MG in 2 ML Injection	PSN	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726324	irinotecan HCl 100 MG in 5 ML Injection	PSN	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726333	irinotecan HCl 300 MG in 15 ML Injection	PSN	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726319	irinotecan HCl 40 MG in 2 ML Injection	PSN	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726335	15 ML irinotecan hydrochloride 20 MG/ML Injection [Camptosar]	SBD	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726321	2 ML irinotecan hydrochloride 20 MG/ML Injection [Camptosar]	SBD	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726325	5 ML irinotecan hydrochloride 20 MG/ML Injection [Camptosar]	SBD	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726333	15 ML irinotecan hydrochloride 20 MG/ML Injection	SCD	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726319	2 ML irinotecan hydrochloride 20 MG/ML Injection	SCD	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726324	5 ML irinotecan hydrochloride 20 MG/ML Injection	SCD	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726335	15 ML Camptosar 20 MG/ML Injection	SY	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726321	2 ML Camptosar 20 MG/ML Injection	SY	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726325	5 ML Camptosar 20 MG/ML Injection	SY	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726325	Camptosar 100 MG per 5 ML Injection	SY	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726335	Camptosar 300 MG per 15 ML Injection	SY	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726321	Camptosar 40 MG per 2 ML Injection	SY	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726324	irinotecan HCl 100 MG per 5 ML Injection	SY	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726333	irinotecan HCl 300 MG per 15 ML Injection	SY	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37
1726319	irinotecan HCl 40 MG per 2 ML Injection	SY	e518dfc6-7e93-4fee-a66c-51e1ab71c056	37

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-7529-03	00009752903	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-7529-03) > 5 mL in 1 VIAL, SINGLE-DOSE	1996-06-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Camptosar	Pharmacia & Upjohn Company LLC \| Zydus Hospira Oncology Private Limited	2026-05-12	HUMAN PRESCRIPTION DRUG LABEL	37