Ferric Citrate

Product NDC: 0378-2895
11-digit product format: 003782895
Labeler code: 0378
Product ID: 0378-2895_8e8396fa-288b-402e-82b0-b1007d1b571f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ferric Citrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA205874
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2025-03-20
Substance: TETRAFERRIC TRICITRATE DECAHYDRATE
Active strength: 210 mg/1
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 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
N205874-001	AURYXIA	FERRIC CITRATE	EQ 210MG IRON	TABLET / ORAL	AB	RLD, RS	2014-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N205874-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205874-001	8093423	2026-04-21	U-1577		2014-10-02
N205874-001	10300039	2030-07-21	U-2549		2019-06-24
N205874-001	9387191	2030-07-21		Drug product	2016-08-09

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 2 · 41 observed 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	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205874-001	AURYXIA	EQ 210MG IRON	TABLET / ORAL	RLD, RS	2014-09-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205874-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 526 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	N205874-001	8093423	2026-04-21	U-1577		2014-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205874-001	10300039	2030-07-21	U-2549		2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205874-001	9387191	2030-07-21		Drug product	2016-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205874-001	8093423	2026-04-21	U-1577		2014-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205874-001	10300039	2030-07-21	U-2549		2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205874-001	9387191	2030-07-21		Drug product	2016-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205874-001	8093423	2026-04-21	U-1577		2014-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205874-001	10300039	2030-07-21	U-2549		2019-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205874-001	9387191	2030-07-21		Drug product	2016-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205874-001	8093423	2026-04-21	U-1577		2014-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205874-001	10300039	2030-07-21	U-2549		2019-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205874-001	9387191	2030-07-21		Drug product	2016-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205874-001	8093423	2026-04-21	U-1577		2014-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205874-001	10300039	2030-07-21	U-2549		2019-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205874-001	9387191	2030-07-21		Drug product	2016-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	7767851	2024-02-18		Drug substance, Drug product	2014-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	8299298	2024-02-18		Drug product	2014-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	8338642	2024-02-18	U-1577	Drug substance, Drug product	2014-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	8609896	2024-02-18		Drug product	2014-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	8754257	2024-02-18		Drug product	2014-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	8754258	2024-02-18		Drug product	2014-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	8846976	2024-02-18	U-1577		2014-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	8901349	2024-02-18	U-1577		2015-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	9050316	2024-02-18	U-1577		2015-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	9328133	2024-02-18	U-1577	Drug substance, Drug product	2016-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	9757416	2024-02-18	U-1577	Drug substance, Drug product	2017-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	8093423	2026-04-21	U-1577		2014-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	10300039	2030-07-21	U-2549		2019-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205874-001	9387191	2030-07-21		Drug product	2016-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	7767851	2024-02-18		Drug substance, Drug product	2014-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	8299298	2024-02-18		Drug product	2014-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	8338642	2024-02-18	U-1577	Drug substance, Drug product	2014-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	8609896	2024-02-18		Drug product	2014-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	8754257	2024-02-18		Drug product	2014-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	8754258	2024-02-18		Drug product	2014-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	8846976	2024-02-18	U-1577		2014-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	8901349	2024-02-18	U-1577		2015-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	9050316	2024-02-18	U-1577		2015-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	9328133	2024-02-18	U-1577	Drug substance, Drug product	2016-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205874-001	9757416	2024-02-18	U-1577	Drug substance, Drug product	2017-10-05	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205874-001	I-790	2020-11-06	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N205874-001	I-790	2020-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205874-001	I-790	2020-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205874-001	I-790	2020-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205874-001	I-790	2020-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205874-001	I-790	2020-11-06	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ferric Citrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TETRAFERRIC TRICITRATE DECAHYDRATE	210 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q91187K011	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1594680	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
8e8396fa-288b-402e-82b0-b1007d1b571f	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
0378-2895-20	Ferric Citrate	200 in 1 BOTTLE	TABLET, FILM COATED	200		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-2895-20	EA - Each	0378-2895	18d0d002-a17e-4cdc-b368-0d916772a235	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-2895	FERRIC CITRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1	Current NDC, 1 package rows	20250322_8e8396fa-288b-402e-82b0-b1007d1b571f.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
Auryxia	FERRIC CITRATE	Akebia Therapeutics, Inc.	aadd18e0-3752-11e4-8510-0800200c9a66	2024-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205874 application number: NDA205874
Ferric Citrate	FERRIC CITRATE	Mylan Pharmaceuticals Inc.	8e8396fa-288b-402e-82b0-b1007d1b571f	2024-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205874 application number: NDA205874 ndc (product): 0378-2895

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
Q91187K011	TETRAFERRIC TRICITRATE DECAHYDRATE	TETRAFERRIC TRICITRATE DECAHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1594680	ferric citrate (as iron) 210 MG Oral Tablet	PSN	8e8396fa-288b-402e-82b0-b1007d1b571f	1
1594680	ferric citrate 1000 MG Oral Tablet	SCD	8e8396fa-288b-402e-82b0-b1007d1b571f	1
1594680	ferric citrate 1 GM (iron 210 MG) Oral Tablet	SY	8e8396fa-288b-402e-82b0-b1007d1b571f	1
1594680	ferric citrate 1 GM Oral Tablet	SY	8e8396fa-288b-402e-82b0-b1007d1b571f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0378-2895-20	00378289520	200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20)	2025-03-20	No	No	Current