Ferric Carboxymaltose

Product NDC: 0781-3542
11-digit product format: 007813542
Labeler code: 0781
Product ID: 0781-3542_4228287d-2252-46bf-a52b-5b2165a702e1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ferric Carboxymaltose Injection
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz, Inc.
Application: NDA203565
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2026-07-03
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: 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 · 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	2020-10-08
N203565-003	INJECTAFER	FERRIC CARBOXYMALTOSE	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD	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 · 149 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
2026-09-14 22:38:34	2026-08	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD	2020-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2021-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2022-02-04	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N203565-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-004	AP	1	`84e616aacf4f…`
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 84 · 3,335 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	N203565-001	11364260	2027-01-08	U-3637		2023-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	11433091	2027-01-08	U-3435		2022-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	11433091	2027-01-08	U-3436		2022-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	11433091	2027-01-08	U-3437		2022-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	11433091	2027-01-08	U-3438		2022-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	11433091	2027-01-08	U-3634		2022-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	11478502	2027-01-08	U-3472		2022-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	11478502	2027-01-08	U-3473		2022-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	11478502	2027-01-08	U-3474		2022-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	8895612	2027-01-08	U-1620		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	8895612	2027-01-08	U-3115		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	8895612	2027-01-08	U-3116		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	8895612	2027-01-08	U-3635		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	8895612	2027-01-08	U-3315		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	8895612	2027-01-08	U-3316		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	7612109	2027-02-05		Drug substance, Drug product	2013-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	7754702	2028-02-15	U-1432		2013-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	7754702	2028-02-15	U-3636		2013-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	7754702	2028-02-15	U-3314		2013-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	7754702	2028-02-15	U-3312		2013-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-001	7754702	2028-02-15	U-3313		2013-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	11364260	2027-01-08	U-3637		2023-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	11433091	2027-01-08	U-3435		2022-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	11433091	2027-01-08	U-3436		2022-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	11433091	2027-01-08	U-3437		2022-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	11433091	2027-01-08	U-3438		2022-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	11433091	2027-01-08	U-3634		2022-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	11478502	2027-01-08	U-3472		2022-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	11478502	2027-01-08	U-3473		2022-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	11478502	2027-01-08	U-3474		2022-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	8895612	2027-01-08	U-3051		2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	8895612	2027-01-08	U-1620		2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	8895612	2027-01-08	U-3050		2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	8895612	2027-01-08	U-3116		2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	8895612	2027-01-08	U-3115		2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	8895612	2027-01-08	U-3635		2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	8895612	2027-01-08	U-3316		2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	8895612	2027-01-08	U-3315		2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	7612109	2027-02-05		Drug substance, Drug product	2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	7754702	2028-02-15	U-2556		2021-02-02	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 193 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	N203565-001	I-915	2026-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-002	I-915	2026-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-003	I-915	2026-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203565-004	I-915	2026-05-31	`84e616aacf4f…`
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…`

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: Ferric Carboxymaltose
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1435169	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
bfdf7447-62e4-48ca-b903-11cb3b211064	Available on FDA.report

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
Ferric Carboxymaltose	FERRIC CARBOXYMALTOSE INJECTION	Sandoz, Inc.	bfdf7447-62e4-48ca-b903-11cb3b211064	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203565 application number: NDA203565 ndc (product): 0781-3542
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0781-3542-94	00781354294	1 VIAL, SINGLE-DOSE in 1 BOX (0781-3542-94) / 15 mL in 1 VIAL, SINGLE-DOSE	2026-07-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ferric Carboxymaltose Injection	Sandoz, Inc. \| American Regent, Inc. \| Vifor (International) Inc.	2026-09-02	HUMAN PRESCRIPTION DRUG LABEL	2