Home NDC 81052-138 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 44 .
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N214907-001 CYTALUX EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-11-29 c2088c7a36db…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 · 210 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N214907-001 10881747 2033-08-26 U-3291 Drug substance, Drug product 2022-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214907-001 9333270 2033-08-26 U-3291 Drug substance, Drug product 2022-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214907-001 9341629 2033-08-26 Drug substance, Drug product 2022-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214907-001 9789208 2033-08-26 U-3291 Drug substance, Drug product 2022-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214907-001 9254341 2033-10-04 Drug substance, Drug product 2022-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214907-001 9061057 2035-11-29 U-3291 Drug substance, Drug product 2022-01-25 c2088c7a36db…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…
Observed Orange Book exclusivity history# Exclusivity history page 2 of 3 · 82 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 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