Home NDC 59630-266 Fetroja
Product NDC 59630-266
11-digit product format 596300266
Labeler code 59630
Product ID 59630-266_64c35e73-1daa-4a82-a3c2-a737dec6eeae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefiderocol sulfate tosylate
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Shionogi Inc.
Application NDA209445
Marketing category NDA
Marketing start 2020-01-31
Substance CEFIDEROCOL SULFATE TOSYLATE
Active strength 1 g/10mL
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
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 N209445-001 FETROJA CEFIDEROCOL SULFATE TOSYLATE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209445-001 9238657 2033-11-14 U-282 Drug substance, Drug product 2019-12-11 N209445-001 9238657 2033-11-14 U-3470 Drug substance, Drug product 2019-12-11 N209445-001 9238657 2033-11-14 U-3471 Drug substance, Drug product 2019-12-11 N209445-001 10004750 2035-09-03 Drug substance, Drug product 2019-12-11 N209445-001 9949982 2035-09-03 Drug product 2019-12-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209445-001 NCE 2024-11-14 N209445-001 GAIN 2029-11-14
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 2026-09-14 22:38:34 2026-08 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209445-001 FETROJA EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2019-11-14 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 172 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 N209445-001 9238657 2033-11-14 U-282 Drug substance, Drug product 2019-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209445-001 9238657 2033-11-14 U-3470 Drug substance, Drug product 2019-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209445-001 9238657 2033-11-14 U-3471 Drug substance, Drug product 2019-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209445-001 10004750 2035-09-03 Drug substance, Drug product 2019-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209445-001 9949982 2035-09-03 Drug product 2019-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209445-001 9238657 2033-11-14 U-282 Drug substance, Drug product 2019-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209445-001 9238657 2033-11-14 U-3470 Drug substance, Drug product 2019-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209445-001 9238657 2033-11-14 U-3471 Drug substance, Drug product 2019-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209445-001 10004750 2035-09-03 Drug substance, Drug product 2019-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209445-001 9949982 2035-09-03 Drug product 2019-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209445-001 9238657 2033-11-14 U-282 Drug substance, Drug product 2019-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209445-001 9238657 2033-11-14 U-3470 Drug substance, Drug product 2019-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209445-001 9238657 2033-11-14 U-3471 Drug substance, Drug product 2019-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209445-001 10004750 2035-09-03 Drug substance, Drug product 2019-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209445-001 9949982 2035-09-03 Drug product 2019-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209445-001 9238657 2033-11-14 U-282 Drug substance, Drug product 2019-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209445-001 9238657 2033-11-14 U-3470 Drug substance, Drug product 2019-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209445-001 9238657 2033-11-14 U-3471 Drug substance, Drug product 2019-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209445-001 10004750 2035-09-03 Drug substance, Drug product 2019-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209445-001 9949982 2035-09-03 Drug product 2019-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209445-001 9238657 2033-11-14 U-282 Drug substance, Drug product 2019-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209445-001 9238657 2033-11-14 U-3470 Drug substance, Drug product 2019-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209445-001 9238657 2033-11-14 U-3471 Drug substance, Drug product 2019-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209445-001 10004750 2035-09-03 Drug substance, Drug product 2019-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209445-001 9949982 2035-09-03 Drug product 2019-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209445-001 9238657 2033-11-14 U-282 Drug substance, Drug product 2019-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209445-001 9238657 2033-11-14 U-3470 Drug substance, Drug product 2019-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209445-001 9238657 2033-11-14 U-3471 Drug substance, Drug product 2019-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209445-001 10004750 2035-09-03 Drug substance, Drug product 2019-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209445-001 9949982 2035-09-03 Drug product 2019-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209445-001 9238657 2033-11-14 U-282 Drug substance, Drug product 2019-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209445-001 9238657 2033-11-14 U-3470 Drug substance, Drug product 2019-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209445-001 9238657 2033-11-14 U-3471 Drug substance, Drug product 2019-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209445-001 10004750 2035-09-03 Drug substance, Drug product 2019-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209445-001 9949982 2035-09-03 Drug product 2019-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209445-001 9238657 2033-11-14 U-282 Drug substance, Drug product 2019-12-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209445-001 9238657 2033-11-14 U-3470 Drug substance, Drug product 2019-12-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209445-001 9238657 2033-11-14 U-3471 Drug substance, Drug product 2019-12-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209445-001 10004750 2035-09-03 Drug substance, Drug product 2019-12-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209445-001 9949982 2035-09-03 Drug product 2019-12-11 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 99 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 Fetroja
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFIDEROCOL SULFATE TOSYLATE 1 g/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TTP8LBP45D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2265706 Internal RxNorm lookup 2265711 Internal RxNorm 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 59630-266-01 Fetroja 10 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, FOR SOLUTION 10 11 59630-266-10 Fetroja 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59630-266 FETROJA (CEFIDEROCOL SULFATE TOSYLATE) INJECTION, POWDER, FOR SOLUTION [SHIONOGI INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240928_75c0c785-38e0-4049-a6fb-b77581f5b35c.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59630-266-01 59630026601 10 mL in 1 VIAL, SINGLE-USE 10 ml Historical 59630-266-10 59630026610 10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01) 2020-01-31 0000-00-00 No No Current