Home NDC 60940-022 Triferic Solution for Hemodialysis
Product NDC 60940-022
11-digit product format 609400022
Labeler code 60940
Product ID 60940-022_cf6f526d-9b1d-ff28-e053-2a95a90a681a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ferric pyrophosphate citrate
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Holopack Verpackungstechnik GmgH
Application NDA212860
Marketing category NDA
Marketing start 2020-06-02
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 2022-12-31
Current FDA listing Historical FDA.report record 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 Product TE source text 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…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60940-022-01 60940002201 8 POUCH in 1 CARTON (60940-022-01) > 10 AMPULE in 1 POUCH > 4.5 mL in 1 AMPULE 8 pouch 2020-06-02 0000-00-00 No No Current