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 1.

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	RLD / RS	Approval date	Source SHA-256
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 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209445-001	9238657	2033-11-14	U-282	Drug substance, Drug product	2019-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209445-001	9238657	2033-11-14	U-3470	Drug substance, Drug product	2019-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209445-001	9238657	2033-11-14	U-3471	Drug substance, Drug product	2019-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209445-001	10004750	2035-09-03		Drug substance, Drug product	2019-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209445-001	9949982	2035-09-03		Drug product	2019-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209445-001	9238657	2033-11-14	U-282	Drug substance, Drug product	2019-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209445-001	9238657	2033-11-14	U-3470	Drug substance, Drug product	2019-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209445-001	9238657	2033-11-14	U-3471	Drug substance, Drug product	2019-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209445-001	10004750	2035-09-03		Drug substance, Drug product	2019-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209445-001	9949982	2035-09-03		Drug product	2019-12-11	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 95 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209445-001	NCE	2024-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209445-001	GAIN	2029-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209445-001	NCE	2024-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209445-001	GAIN	2029-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209445-001	NCE	2024-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209445-001	GAIN	2029-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209445-001	NCE	2024-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209445-001	GAIN	2029-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209445-001	NCE	2024-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209445-001	GAIN	2029-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209445-001	NCE	2024-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209445-001	GAIN	2029-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209445-001	NCE	2024-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209445-001	GAIN	2029-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209445-001	NCE	2024-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209445-001	GAIN	2029-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209445-001	NCE	2024-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209445-001	GAIN	2029-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209445-001	NCE	2024-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209445-001	GAIN	2029-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209445-001	NCE	2024-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209445-001	GAIN	2029-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209445-001	NCE	2024-11-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209445-001	GAIN	2029-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209445-001	NCE	2024-11-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209445-001	GAIN	2029-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209445-001	NCE	2024-11-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209445-001	GAIN	2029-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209445-001	I-844	2023-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209445-001	NCE	2024-11-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209445-001	GAIN	2029-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209445-001	I-844	2023-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209445-001	NCE	2024-11-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209445-001	GAIN	2029-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209445-001	I-844	2023-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209445-001	NCE	2024-11-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209445-001	GAIN	2029-11-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209445-001	I-844	2023-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209445-001	NCE	2024-11-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209445-001	GAIN	2029-11-14	`bb7c543d1eb4…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
75c0c785-38e0-4049-a6fb-b77581f5b35c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2bbc5324-1064-4ef2-953c-4c9fb2e47aaa	Product name	1	20200429

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59630-266-01	EA - Each	59630-266	b16f68cf-47eb-44f5-84ad-9314e465cf8f	1	2020-03-10
59630-266-10	EA - Each	59630-266	e7235c49-783f-411e-92d9-9cf933717ed0	1	2020-03-10

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fetroja	CEFIDEROCOL SULFATE TOSYLATE	Shionogi Inc.	75c0c785-38e0-4049-a6fb-b77581f5b35c	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209445 application number: NDA209445 ndc (product): 59630-266

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TTP8LBP45D	CEFIDEROCOL SULFATE TOSYLATE	2135543-94-9	CEFIDEROCOL SULFATE TOSYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2265706	cefiderocol 1 GM Injection	PSN	75c0c785-38e0-4049-a6fb-b77581f5b35c	11
2265711	FETROJA 1 GM Injection	PSN	75c0c785-38e0-4049-a6fb-b77581f5b35c	11
2265711	cefiderocol 1000 MG Injection [Fetroja]	SBD	75c0c785-38e0-4049-a6fb-b77581f5b35c	11
2265706	cefiderocol 1000 MG Injection	SCD	75c0c785-38e0-4049-a6fb-b77581f5b35c	11
2265706	cefiderocol (as cefiderocol sulfate tosylate) 1 GM Injection	SY	75c0c785-38e0-4049-a6fb-b77581f5b35c	11
2265711	Fetroja 1 GM Injection	SY	75c0c785-38e0-4049-a6fb-b77581f5b35c	11
2265711	Fetroja 1000 MG Injection	SY	75c0c785-38e0-4049-a6fb-b77581f5b35c	11

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