Triferic AVNU

Product NDC: 57278-318
11-digit product format: 572780318
Labeler code: 57278
Product ID: 57278-318_af5e4041-2fca-6927-e053-2995a90aa402
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ferric pyrophosphate citrate
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Rockwell Medical Inc.
Application: NDA212860
Marketing category: NDA
Marketing start: 2020-03-30
Marketing end: 0000-00-00
Substance: FERRIC PYROPHOSPHATE CITRATE
Active strength: 2 mg/mL
Pharmacologic classes: Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57278-318		I	Inactivated by FDA	2026-08-17
excluded package	package	57278-318	57278-318-02	I	Inactivated by FDA	2026-08-17
excluded package	package	57278-318	57278-318-11	I	Inactivated by FDA	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57278-318-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57278-318-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57278-318-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57278-318-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57278-318-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57278-318-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57278-318-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57278-318-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57278-318-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57278-318-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57278-318-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57278-318-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57278-318-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57278-318-11	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57278-318-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57278-318-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57278-318-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57278-318-11	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57278-318-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57278-318-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57278-318-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57278-318-11	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57278-318-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57278-318-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57278-318-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57278-318-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57278-318-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57278-318-11	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57278-318-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57278-318-11	`1332a3947898…`	`d4bfe170f9cd…`

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

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
N212860-001	TRIFERIC AVNU	FERRIC PYROPHOSPHATE CITRATE	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD	2020-03-27

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28

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
2026-08-18 06:07:40	2026-07	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-03-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212860-001	TRIFERIC AVNU	6.75MG IRON/4.5ML (1.5MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD	2020-03-27	`a50c72e98297…`

Observed Orange Book patent history#

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	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212860-001	7816404	2029-04-17	U-2801	Drug substance	2020-04-28	`a50c72e98297…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57278-318-02	2023-01-30	C162847	48780-1	f386c64a-279b-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRIFERIC AVNU safely and effectively. See full prescribing information for TRIFERIC AVNU. TRIFERIC ® AVNU (ferric pyrophosphate citrate injection), for intravenous use Initial U.S. Approval: 2015
57278-318-11	2023-01-30	C162847	48780-1	f386c64a-279b-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRIFERIC AVNU safely and effectively. See full prescribing information for TRIFERIC AVNU. TRIFERIC ® AVNU (ferric pyrophosphate citrate injection), for intravenous use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57278-318-01	Triferic AVNU	10 in 1 POUCH	SOLUTION	10	3
57278-318-01	Triferic AVNU	4.5 mL in 1 AMPULE	SOLUTION	4.5	3
57278-318-02	Triferic AVNU	4 in 1 CARTON	SOLUTION	4	3
57278-318-11	Triferic AVNU	4.5 mL in 1 AMPULE	SOLUTION	4.5	3
57278-318-11	Triferic AVNU	1 in 1 POUCH	SOLUTION	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57278-318	TRIFERIC AVNU (FERRIC PYROPHOSPHATE CITRATE) SOLUTION [ROCKWELL MEDICAL INC.]	3	Legacy NDC, 5 package rows	20200916_51197a48-6078-42cd-b5ed-5ea22b6757b4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UBY79OCO9G	FERRIC PYROPHOSPHATE CITRATE	1802359-96-1	FERRIC PYROPHOSPHATE CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2287755	ferric pyrophosphate citrate (as iron) 6.75 MG in 4.5 mL hemodialysis Injection	PSN	51197a48-6078-42cd-b5ed-5ea22b6757b4	3
2287757	Triferic (iron) 6.75 MG in 4.5 mL hemodialysis Injection	PSN	51197a48-6078-42cd-b5ed-5ea22b6757b4	3
2287757	4.5 ML ferric pyrophosphate citrate 1.5 MG/ML Injection [Triferic]	SBD	51197a48-6078-42cd-b5ed-5ea22b6757b4	3
2287755	4.5 ML ferric pyrophosphate citrate 1.5 MG/ML Injection	SCD	51197a48-6078-42cd-b5ed-5ea22b6757b4	3
2287757	4.5 ML Triferic 1.5 MG/ML Injection	SY	51197a48-6078-42cd-b5ed-5ea22b6757b4	3
2287755	ferric pyrophosphate citrate (as elemental iron) 6.75 MG per 4.5 ML hemodialysis Injection	SY	51197a48-6078-42cd-b5ed-5ea22b6757b4	3
2287757	Triferic (as elemental iron) 6.75 MG per 4.5 ML hemodialysis Injection	SY	51197a48-6078-42cd-b5ed-5ea22b6757b4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57278-318-01	57278031801	10 in 1 POUCH						Historical
57278-318-02	57278031802	4 POUCH in 1 CARTON (57278-318-02) > 10 AMPULE in 1 POUCH (57278-318-01) > 4.5 mL in 1 AMPULE	4 pouch	2020-03-30	0000-00-00	No	No	Current
57278-318-11	57278031811	1 AMPULE in 1 POUCH (57278-318-11) > 4.5 mL in 1 AMPULE	1 ampule	2020-09-15	0000-00-00	Yes	No	Current