Home NDC 73059-001-10 ACCRUFER
Product NDC 73059-001
Requested package NDC 73059-001-10
11-digit product format 730590001
Labeler code 73059
Product ID 73059-001_4692a8dd-4627-f0eb-e063-6294a90aed63
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ferric Maltol
Dosage form CAPSULE
Route ORAL
Labeler Shield TX (UK) Ltd
Application NDA212320
Marketing category NDA
Marketing start 2021-07-01
Substance FERRIC MALTOL
Active strength 30 mg/1
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212320-001 ACCRUFER FERRIC MALTOL 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25
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 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212320-001 NPP 2028-12-19
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 · 42 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 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD 2019-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD 2019-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD 2019-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD 2019-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212320-001 ACCRUFER 30MG IRON CAPSULE / ORAL RLD, RS 2019-07-25 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 4 · 126 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 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212320-001 10179120 2035-01-06 U-2603 2019-08-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212320-001 9802973 2035-10-23 U-2603 Drug substance, Drug product 2019-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212320-001 9248148 2031-03-29 U-2603 2019-08-22 301d65b070ca…
Observed Orange Book exclusivity history# 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 ACCRUFER
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC MALTOL 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MA10QYF1Z0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2539943 Internal RxNorm lookup 2539949 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73059-001 ACCRUFER (FERRIC MALTOL) CAPSULE [SHIELD TX (UK) LTD] 22 Current NDC, Legacy NDC, 6 package rows 20231207_367ac157-2d25-4f34-99ce-b126e0f03851.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 73059-001-10 73059000110 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-10) / 10 CAPSULE in 1 BOTTLE, PLASTIC 2022-04-01 0000-00-00 Yes No Current