Injectafer

Product NDC: 0517-0602
11-digit product format: 005170602
Labeler code: 0517
Product ID: 0517-0602_a092ebb6-505b-464f-9669-194a913ff8e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ferric Carboxymaltose Injection
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: American Regent, Inc.
Application: NDA203565
Marketing category: NDA
Marketing start: 2022-06-01
Substance: FERRIC CARBOXYMALTOSE
Active strength: 50 mg/mL
Pharmacologic classes: Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203565-001	INJECTAFER	FERRIC CARBOXYMALTOSE	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-07-25
N203565-002	INJECTAFER	FERRIC CARBOXYMALTOSE	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08
N203565-003	INJECTAFER	FERRIC CARBOXYMALTOSE	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-28
N203565-004	INJECTAFER	FERRIC CARBOXYMALTOSE	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2022-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203565-001	AP
N203565-003	AP
N203565-004	AP

Orange Book patents#

Current patent rows page 1 of 2 · 90 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203565-001	11364260	2027-01-08	U-3637		2023-06-28
N203565-001	11433091	2027-01-08	U-3435		2022-10-04
N203565-001	11433091	2027-01-08	U-3436		2022-10-04
N203565-001	11433091	2027-01-08	U-3437		2022-10-04
N203565-001	11433091	2027-01-08	U-3438		2022-10-04
N203565-001	11433091	2027-01-08	U-3634		2022-10-04
N203565-001	11478502	2027-01-08	U-3472		2022-11-21
N203565-001	11478502	2027-01-08	U-3473		2022-11-21
N203565-001	11478502	2027-01-08	U-3474		2022-11-21
N203565-001	8895612	2027-01-08	U-1620		2014-12-17
N203565-001	8895612	2027-01-08	U-3115		2014-12-17
N203565-001	8895612	2027-01-08	U-3116		2014-12-17
N203565-001	8895612	2027-01-08	U-3315		2014-12-17
N203565-001	8895612	2027-01-08	U-3316		2014-12-17
N203565-001	8895612	2027-01-08	U-3635		2014-12-17
N203565-001	7612109	2027-02-05		Drug substance, Drug product	2013-09-12
N203565-001	7754702	2028-02-15	U-1432		2013-09-12
N203565-001	7754702	2028-02-15	U-3312		2013-09-12
N203565-001	7754702	2028-02-15	U-3313		2013-09-12
N203565-001	7754702	2028-02-15	U-3314		2013-09-12
N203565-001	7754702	2028-02-15	U-3636		2013-09-12
N203565-002	11364260	2027-01-08	U-3637		2023-06-28
N203565-002	11433091	2027-01-08	U-3435		2022-10-04
N203565-002	11433091	2027-01-08	U-3436		2022-10-04
N203565-002	11433091	2027-01-08	U-3437		2022-10-04
N203565-002	11433091	2027-01-08	U-3438		2022-10-04
N203565-002	11433091	2027-01-08	U-3634		2022-10-04
N203565-002	11478502	2027-01-08	U-3472		2022-11-21
N203565-002	11478502	2027-01-08	U-3473		2022-11-21
N203565-002	11478502	2027-01-08	U-3474		2022-11-21
N203565-002	8895612	2027-01-08	U-1620		2021-02-02
N203565-002	8895612	2027-01-08	U-3050		2021-02-02
N203565-002	8895612	2027-01-08	U-3051		2021-02-02
N203565-002	8895612	2027-01-08	U-3115		2021-02-02
N203565-002	8895612	2027-01-08	U-3116		2021-02-02
N203565-002	8895612	2027-01-08	U-3315		2021-02-02
N203565-002	8895612	2027-01-08	U-3316		2021-02-02
N203565-002	8895612	2027-01-08	U-3635		2021-02-02
N203565-002	7612109	2027-02-05		Drug substance, Drug product	2021-02-02
N203565-002	7754702	2028-02-15	U-2555		2021-02-02
N203565-002	7754702	2028-02-15	U-2556		2021-02-02
N203565-002	7754702	2028-02-15	U-2557		2021-02-02
N203565-002	7754702	2028-02-15	U-3312		2021-02-02
N203565-002	7754702	2028-02-15	U-3313		2021-02-02
N203565-002	7754702	2028-02-15	U-3314		2021-02-02
N203565-002	7754702	2028-02-15	U-3636		2021-02-02
N203565-003	11364260	2027-01-08	U-3637		2023-06-28
N203565-003	11433091	2027-01-08	U-3435		2022-10-04
N203565-003	11433091	2027-01-08	U-3436		2022-10-04
N203565-003	11433091	2027-01-08	U-3437		2022-10-04
N203565-003	11433091	2027-01-08	U-3438		2022-10-04
N203565-003	11433091	2027-01-08	U-3634		2022-10-04
N203565-003	11478502	2027-01-08	U-3472		2022-11-21
N203565-003	11478502	2027-01-08	U-3473		2022-11-21
N203565-003	11478502	2027-01-08	U-3474		2022-11-21
N203565-003	8895612	2027-01-08	U-1620		2021-05-21
N203565-003	8895612	2027-01-08	U-3050		2021-05-21
N203565-003	8895612	2027-01-08	U-3051		2021-05-21
N203565-003	8895612	2027-01-08	U-3115		2021-05-21
N203565-003	8895612	2027-01-08	U-3116		2021-05-21
N203565-003	8895612	2027-01-08	U-3315		2021-05-21
N203565-003	8895612	2027-01-08	U-3316		2021-05-21
N203565-003	8895612	2027-01-08	U-3635		2021-05-21
N203565-003	7612109	2027-02-05		Drug substance, Drug product	2021-05-21
N203565-003	7754702	2028-02-15	U-2555		2021-05-21
N203565-003	7754702	2028-02-15	U-2556		2021-05-21
N203565-003	7754702	2028-02-15	U-2557		2021-05-21
N203565-003	7754702	2028-02-15	U-3312		2021-05-21
N203565-003	7754702	2028-02-15	U-3313		2021-05-21
N203565-003	7754702	2028-02-15	U-3314		2021-05-21
N203565-003	7754702	2028-02-15	U-3636		2021-05-21
N203565-004	11364260	2027-01-08	U-3637		2023-06-28
N203565-004	11433091	2027-01-08	U-3435		2022-10-04
N203565-004	11433091	2027-01-08	U-3436		2022-10-04
N203565-004	11433091	2027-01-08	U-3437		2022-10-04
N203565-004	11433091	2027-01-08	U-3438		2022-10-04
N203565-004	11433091	2027-01-08	U-3634		2022-10-04
N203565-004	11478502	2027-01-08	U-3472		2022-11-21
N203565-004	11478502	2027-01-08	U-3473		2022-11-21
N203565-004	11478502	2027-01-08	U-3474		2022-11-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203565-001	I-915	2026-05-31
N203565-002	I-915	2026-05-31
N203565-003	I-915	2026-05-31
N203565-004	I-915	2026-05-31

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 · 145 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
2026-08-18 06:07:40	2026-07	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2022-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N203565-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-004	AP	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203565-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203565-003	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203565-004	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 82 · 3,245 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203565-001	11364260	2027-01-08	U-3637		2023-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11433091	2027-01-08	U-3435		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11433091	2027-01-08	U-3436		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11433091	2027-01-08	U-3437		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11433091	2027-01-08	U-3438		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11433091	2027-01-08	U-3634		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11478502	2027-01-08	U-3472		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11478502	2027-01-08	U-3473		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11478502	2027-01-08	U-3474		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-1620		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-3115		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-3116		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-3635		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-3315		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-3316		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7612109	2027-02-05		Drug substance, Drug product	2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7754702	2028-02-15	U-1432		2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7754702	2028-02-15	U-3636		2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7754702	2028-02-15	U-3314		2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7754702	2028-02-15	U-3312		2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7754702	2028-02-15	U-3313		2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11364260	2027-01-08	U-3637		2023-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11433091	2027-01-08	U-3435		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11433091	2027-01-08	U-3436		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11433091	2027-01-08	U-3437		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11433091	2027-01-08	U-3438		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11433091	2027-01-08	U-3634		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11478502	2027-01-08	U-3472		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11478502	2027-01-08	U-3473		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11478502	2027-01-08	U-3474		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3051		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-1620		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3050		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3116		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3115		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3635		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3316		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3315		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	7612109	2027-02-05		Drug substance, Drug product	2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	7754702	2028-02-15	U-2556		2021-02-02	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 189 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N203565-001	I-915	2026-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	I-915	2026-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-003	I-915	2026-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-004	I-915	2026-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203565-001	I-915	2026-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-002	I-915	2026-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-003	I-915	2026-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-004	I-915	2026-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-001	I-915	2026-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-002	I-915	2026-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-003	I-915	2026-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-004	I-915	2026-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203565-001	I-915	2026-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-002	I-915	2026-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-003	I-915	2026-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-004	I-915	2026-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-001	I-915	2026-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-002	I-915	2026-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-003	I-915	2026-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-004	I-915	2026-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-001	I-915	2026-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-002	I-915	2026-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-003	I-915	2026-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-004	I-915	2026-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-001	NPP	2024-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-001	I-915	2026-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-002	NPP	2024-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-002	I-915	2026-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-003	NS	2024-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-003	NPP	2024-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-003	I-915	2026-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-004	I-915	2026-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-001	NPP	2024-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-001	I-915	2026-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-002	NPP	2024-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-002	I-915	2026-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-003	NS	2024-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-003	NPP	2024-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-003	I-915	2026-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-004	I-915	2026-05-31	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC CARBOXYMALTOSE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6897GXD6OE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1435169	Internal RxNorm lookup
1435174	Internal RxNorm lookup
2552400	Internal RxNorm lookup
2552401	Internal RxNorm lookup
2602296	Internal RxNorm lookup
2602297	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
517b4a19-45b3-4286-9f6a-ced4e10447de	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
04cdd491-d111-4bc2-9549-75c575e1bd4b	Product name	1	20200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73	Product name	1	20200611
96a528e9-23e2-495f-81b9-ae87df2f7552	Product name	1	20191120
3df56c93-5837-4523-aac2-4b1ec48b9676	Product name	2	20160719
a883b7cc-d320-41d7-92ae-c873457ae641	Product name	1	20151116
bb23e78e-9e64-4037-a1c1-0e1d8762700e	Product name	1	20150325
ef06c001-572c-d95e-42f6-ee83da75673a	Product name	1	20140508
fd21f957-6863-d07b-5a35-250186878716	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0517-0602-01	Injectafer	1 in 1 BOX	INJECTION, SOLUTION	1		29
0517-0602-01	Injectafer	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-0602-01	ML - Milliliter	0517-0602	5b25ca95-5457-4a29-b317-dafeeffbd95d	1	2022-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FERRIC CARBOXYMALTOSE	ACTIVE INGREDIENT	6897GXD6OE	INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3
FERRIC CATION	ACTIVE MOIETY	91O4LML611	INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-0602	INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION INJECTAFER (FERRIC CARBOXYMALTOSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.]	29	Current NDC, Legacy NDC, 2 package rows	20250108_517b4a19-45b3-4286-9f6a-ced4e10447de.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Injectafer	FERRIC CARBOXYMALTOSE INJECTION	American Regent, Inc.	517b4a19-45b3-4286-9f6a-ced4e10447de	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203565 application number: NDA203565 ndc (product): 0517-0602
Ferric Carboxymaltose	FERRIC CARBOXYMALTOSE INJECTION	Sandoz, Inc.	bfdf7447-62e4-48ca-b903-11cb3b211064	2026-02-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203565 application number: NDA203565

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6897GXD6OE	FERRIC CARBOXYMALTOSE	9007-72-1	FERRIC CARBOXYMALTOSE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1435169	ferric carboxymaltose (as iron) 750 MG in 15 mL Injection	PSN	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2552400	ferric carboxymaltose (iron) 1000 MG in 20 mL Injection	PSN	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2602296	ferric carboxymaltose 100 MG in 2 ML Injection	PSN	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2602297	Injectafer (iron) 100 MG in 2 mL Injection	PSN	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2552401	Injectafer (iron) 1000 MG in 20 ML Injection	PSN	517b4a19-45b3-4286-9f6a-ced4e10447de	29
1435174	Injectafer (iron) 750 MG in 15 mL Injection	PSN	517b4a19-45b3-4286-9f6a-ced4e10447de	29
1435174	15 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer]	SBD	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2602297	2 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer]	SBD	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2552401	20 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer]	SBD	517b4a19-45b3-4286-9f6a-ced4e10447de	29
1435169	15 ML ferric carboxymaltose 50 MG/ML Injection	SCD	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2602296	2 ML ferric carboxymaltose 50 MG/ML Injection	SCD	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2552400	20 ML ferric carboxymaltose 50 MG/ML Injection	SCD	517b4a19-45b3-4286-9f6a-ced4e10447de	29
1435174	15 ML Injectafer 50 MG/ML Injection	SY	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2602297	2 ML Injectafer 50 MG/ML Injection	SY	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2552401	20 ML Injectafer 50 MG/ML Injection	SY	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2552400	ferric carboxymaltose (as elemental iron) 1000 MG per 20 ML Injection	SY	517b4a19-45b3-4286-9f6a-ced4e10447de	29
1435169	ferric carboxymaltose (as elemental iron) 750 MG per 15 ML Injection	SY	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2602296	ferric carboxymaltose 100 MG per 2 ML Injection	SY	517b4a19-45b3-4286-9f6a-ced4e10447de	29
2552401	Injectafer (as elemental iron) 1000 MG per 20 ML Injection	SY	517b4a19-45b3-4286-9f6a-ced4e10447de	29
1435174	Injectafer (as elemental iron) 750 MG per 15 ML Injection	SY	517b4a19-45b3-4286-9f6a-ced4e10447de	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-0602-01	00517060201	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2022-07-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ferric Carboxymaltose Injection	American Regent, Inc. \| Vifor (International) Inc.	2026-08-19	HUMAN PRESCRIPTION DRUG LABEL	30