Home NDC 73594-9301 Monoferric
Product NDC 73594-9301
11-digit product format 735949301
Labeler code 73594
Product ID 73594-9301_ddb3125c-a423-4256-9017-6e614ae2263d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ferric derisomaltose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Pharmacosmos Therapeutics Inc.
Application NDA208171
Marketing category NDA
Marketing start 2020-01-16
Substance FERRIC DERISOMALTOSE
Active strength 100 mg/mL
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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208171-001 MONOFERRIC FERRIC DERISOMALTOSE 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 N208171-002 MONOFERRIC FERRIC DERISOMALTOSE 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 N208171-003 MONOFERRIC FERRIC DERISOMALTOSE 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208171-001 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 N208171-001 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 N208171-001 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 N208171-001 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 N208171-001 11633489 2036-06-22 U-3594 2023-05-24 N208171-002 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 N208171-002 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 N208171-002 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 N208171-002 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 N208171-002 11633489 2036-06-22 U-3594 2023-05-24 N208171-003 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 N208171-003 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 N208171-003 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 N208171-003 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 N208171-003 11633489 2036-06-22 U-3594 2023-05-24
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 3 · 117 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 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208171-002 MONOFERRIC 500MG/5ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208171-003 MONOFERRIC 1GM/10ML (100MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208171-001 MONOFERRIC 100MG/ML (100MG/ML) SOLUTION / INTRAVENOUS RLD 2020-01-16 301d65b070ca…
Observed Orange Book patent history# Patent history page 1 of 10 · 386 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 N208171-001 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-001 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-001 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-001 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-001 11633489 2036-06-22 U-3594 2023-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-002 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-002 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-002 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-002 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-002 11633489 2036-06-22 U-3594 2023-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-003 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-003 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-003 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-003 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208171-003 11633489 2036-06-22 U-3594 2023-05-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208171-001 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-001 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-001 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-001 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-001 11633489 2036-06-22 U-3594 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-002 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-002 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-002 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-002 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-002 11633489 2036-06-22 U-3594 2023-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-003 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-003 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-003 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-003 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208171-003 11633489 2036-06-22 U-3594 2023-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208171-001 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-001 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-001 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-001 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-001 11633489 2036-06-22 U-3594 2023-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-002 10414831 2029-03-25 Drug substance, Drug product 2020-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-002 11851504 2029-03-25 Drug substance, Drug product 2024-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-002 12030962 2029-03-25 Drug substance, Drug product 2024-08-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-002 8815301 2029-08-14 U-2734 Drug substance, Drug product 2020-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208171-002 11633489 2036-06-22 U-3594 2023-05-24 011fe1cb6892…
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 Monoferric
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC DERISOMALTOSE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AHU547PI9H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2274398 Internal RxNorm lookup 2274403 Internal RxNorm lookup 2274406 Internal RxNorm lookup 2274407 Internal RxNorm lookup 2274408 Internal RxNorm lookup 2274409 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73594-9301-2 Monoferric 5 in 1 BOX INJECTION, SOLUTION 5 13 73594-9301-3 Monoferric 1 mL in 1 VIAL INJECTION, SOLUTION 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73594-9301 MONOFERRIC (FERRIC DERISOMALTOSE) INJECTION, SOLUTION [PHARMACOSMOS THERAPEUTICS INC.] 12 Current NDC, Legacy NDC, 2 package rows 20240920_55859d2d-0456-4fa9-b41f-f535accc97db.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 Units Marketing start Marketing end Sample Exclude flag Status 73594-9301-2 73594930102 5 VIAL in 1 BOX (73594-9301-2) / 1 mL in 1 VIAL (73594-9301-3) 5 vial 2020-01-16 0000-00-00 No No Current 73594-9301-3 73594930103 1 mL in 1 VIAL 1 ml Historical