Cytalux

Product NDC: 81052-138
11-digit product format: 810520138
Labeler code: 81052
Product ID: 81052-138_4cc23694-63af-f9f1-e063-6394a90a4ce0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pafolacianine injection
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: On Target Laboratories, Inc.
Application: NDA214907
Marketing category: NDA
Marketing start: 2021-11-29
Substance: PAFOLACIANINE SODIUM
Active strength: 3.2 mg/1.6mL
Pharmacologic classes: Fluorescence Contrast Activity [MoA], Optical Imaging Agent [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214907-001	CYTALUX	PAFOLACIANINE SODIUM	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-29

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25
N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25
N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25
N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25
N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25
N214907-001	9061057	2035-11-29	U-3291	Drug substance, Drug product	2022-01-25

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214907-001	NCE	2026-11-29
N214907-001	ODE-390	2028-11-29

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	9061057	2035-11-29	U-3291	Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	9061057	2035-11-29	U-3291	Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	9061057	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	9061057	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	9061057	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	9061057	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	9061057	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N214907-001	NCE	2026-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	ODE-390	2028-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214907-001	NCE	2026-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	ODE-390	2028-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214907-001	NCE	2026-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	ODE-390	2028-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	I-905	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	NCE	2026-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	ODE-390	2028-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214907-001	I-905	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	NCE	2026-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	ODE-390	2028-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	I-905	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	NCE	2026-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	ODE-390	2028-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	I-905	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	NCE	2026-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	ODE-390	2028-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214907-001	I-905	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214907-001	NCE	2026-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214907-001	ODE-390	2028-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214907-001	I-905	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214907-001	NCE	2026-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214907-001	ODE-390	2028-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214907-001	I-905	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214907-001	NCE	2026-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214907-001	ODE-390	2028-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214907-001	I-905	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214907-001	NCE	2026-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214907-001	ODE-390	2028-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214907-001	I-905	2025-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214907-001	NCE	2026-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214907-001	ODE-390	2028-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214907-001	I-905	2025-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214907-001	NCE	2026-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214907-001	ODE-390	2028-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214907-001	I-905	2025-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214907-001	NCE	2026-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214907-001	ODE-390	2028-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214907-001	I-905	2025-12-16	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PAFOLACIANINE SODIUM	3.2 mg/1.6mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4HUF3V875C	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d21952b9-7c4e-3a56-e053-2a95a90a0ab0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
e3b0871b-9b8a-45f1-850c-861429b39165	Product name	1	20220706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81052-138-01	Cytalux	1.6 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1.6	10
81052-138-10	Cytalux	10 in 1 CARTON	INJECTION	10	10
81052-138-10	Cytalux	1 in 1 CARTON	INJECTION	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81052-138-10	ML - Milliliter	81052-138	177c4a43-7bd2-4b5d-a856-c4cd63b650d7	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81052-138	CYTALUX (PAFOLACIANINE INJECTION) INJECTION [ON TARGET LABORATORIES, INC.]	6	Current NDC, Legacy NDC, 3 package rows	20241016_d21952b9-7c4e-3a56-e053-2a95a90a0ab0.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
Cytalux	PAFOLACIANINE INJECTION	On Target Laboratories, Inc.	d21952b9-7c4e-3a56-e053-2a95a90a0ab0	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214907 application number: NDA214907 ndc (product): 81052-138

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81052-138-01	81052013801	1.6 mL in 1 VIAL, SINGLE-DOSE	1.6 ml					Historical
81052-138-10	81052013810	10 CARTON in 1 CARTON (81052-138-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.6 mL in 1 VIAL, SINGLE-DOSE (81052-138-01)	10 carton	2021-11-29	0000-00-00	No	No	Current