Monoferric

Product NDC
73594-9310
Requested package NDC
73594-9310-1
11-digit product format
735949310
Labeler code
73594
Product ID
73594-9310_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
1000 mg/10mL
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208171-001MONOFERRICFERRIC DERISOMALTOSE100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16
N208171-002MONOFERRICFERRIC DERISOMALTOSE500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16
N208171-003MONOFERRICFERRIC DERISOMALTOSE1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-16

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208171-001104148312029-03-25Drug substance, Drug product2020-02-14
N208171-001118515042029-03-25Drug substance, Drug product2024-01-11
N208171-001120309622029-03-25Drug substance, Drug product2024-08-05
N208171-00188153012029-08-14U-2734Drug substance, Drug product2020-02-14
N208171-001116334892036-06-22U-35942023-05-24
N208171-002104148312029-03-25Drug substance, Drug product2020-02-14
N208171-002118515042029-03-25Drug substance, Drug product2024-01-11
N208171-002120309622029-03-25Drug substance, Drug product2024-08-05
N208171-00288153012029-08-14U-2734Drug substance, Drug product2020-02-14
N208171-002116334892036-06-22U-35942023-05-24
N208171-003104148312029-03-25Drug substance, Drug product2020-02-14
N208171-003118515042029-03-25Drug substance, Drug product2024-01-11
N208171-003120309622029-03-25Drug substance, Drug product2024-08-05
N208171-00388153012029-08-14U-2734Drug substance, Drug product2020-02-14
N208171-003116334892036-06-22U-35942023-05-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-1684e616aacf4f…
2026-09-14 22:38:342026-08N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-1684e616aacf4f…
2026-09-14 22:38:342026-08N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-1684e616aacf4f…
2026-08-18 06:07:402026-07N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208171-002MONOFERRIC500MG/5ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208171-003MONOFERRIC1GM/10ML (100MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-01-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208171-001MONOFERRIC100MG/ML (100MG/ML)SOLUTION / INTRAVENOUSRLD2020-01-16301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 10 · 386 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N208171-001104148312029-03-25Drug substance, Drug product2020-02-1484e616aacf4f…
2026-09-14 22:38:342026-08N208171-001118515042029-03-25Drug substance, Drug product2024-01-1184e616aacf4f…
2026-09-14 22:38:342026-08N208171-001120309622029-03-25Drug substance, Drug product2024-08-0584e616aacf4f…
2026-09-14 22:38:342026-08N208171-00188153012029-08-14U-2734Drug substance, Drug product2020-02-1484e616aacf4f…
2026-09-14 22:38:342026-08N208171-001116334892036-06-22U-35942023-05-2484e616aacf4f…
2026-09-14 22:38:342026-08N208171-002104148312029-03-25Drug substance, Drug product2020-02-1484e616aacf4f…
2026-09-14 22:38:342026-08N208171-002118515042029-03-25Drug substance, Drug product2024-01-1184e616aacf4f…
2026-09-14 22:38:342026-08N208171-002120309622029-03-25Drug substance, Drug product2024-08-0584e616aacf4f…
2026-09-14 22:38:342026-08N208171-00288153012029-08-14U-2734Drug substance, Drug product2020-02-1484e616aacf4f…
2026-09-14 22:38:342026-08N208171-002116334892036-06-22U-35942023-05-2484e616aacf4f…
2026-09-14 22:38:342026-08N208171-003104148312029-03-25Drug substance, Drug product2020-02-1484e616aacf4f…
2026-09-14 22:38:342026-08N208171-003118515042029-03-25Drug substance, Drug product2024-01-1184e616aacf4f…
2026-09-14 22:38:342026-08N208171-003120309622029-03-25Drug substance, Drug product2024-08-0584e616aacf4f…
2026-09-14 22:38:342026-08N208171-00388153012029-08-14U-2734Drug substance, Drug product2020-02-1484e616aacf4f…
2026-09-14 22:38:342026-08N208171-003116334892036-06-22U-35942023-05-2484e616aacf4f…
2026-08-18 06:07:402026-07N208171-001104148312029-03-25Drug substance, Drug product2020-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-001118515042029-03-25Drug substance, Drug product2024-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-001120309622029-03-25Drug substance, Drug product2024-08-05caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-00188153012029-08-14U-2734Drug substance, Drug product2020-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-001116334892036-06-22U-35942023-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-002104148312029-03-25Drug substance, Drug product2020-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-002118515042029-03-25Drug substance, Drug product2024-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-002120309622029-03-25Drug substance, Drug product2024-08-05caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-00288153012029-08-14U-2734Drug substance, Drug product2020-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-002116334892036-06-22U-35942023-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-003104148312029-03-25Drug substance, Drug product2020-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-003118515042029-03-25Drug substance, Drug product2024-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-003120309622029-03-25Drug substance, Drug product2024-08-05caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-00388153012029-08-14U-2734Drug substance, Drug product2020-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N208171-003116334892036-06-22U-35942023-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208171-001104148312029-03-25Drug substance, Drug product2020-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-001118515042029-03-25Drug substance, Drug product2024-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-001120309622029-03-25Drug substance, Drug product2024-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-00188153012029-08-14U-2734Drug substance, Drug product2020-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-001116334892036-06-22U-35942023-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-002104148312029-03-25Drug substance, Drug product2020-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-002118515042029-03-25Drug substance, Drug product2024-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-002120309622029-03-25Drug substance, Drug product2024-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-00288153012029-08-14U-2734Drug substance, Drug product2020-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208171-002116334892036-06-22U-35942023-05-24011fe1cb6892…

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
IngredientStrength
FERRIC DERISOMALTOSE1000 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AHU547PI9HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2274398Internal RxNorm lookup
2274403Internal RxNorm lookup
2274406Internal RxNorm lookup
2274407Internal RxNorm lookup
2274408Internal RxNorm lookup
2274409Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55859d2d-0456-4fa9-b41f-f535accc97dbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73594-9310-1Monoferric10 mL in 1 VIALINJECTION, SOLUTION1013
73594-9310-1Monoferric1 in 1 BOXINJECTION, SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73594-9310-1ML - Milliliter73594-93100e3c98f7-bb46-410e-9c03-01c4ebebf2fd12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73594-9310MONOFERRIC (FERRIC DERISOMALTOSE) INJECTION, SOLUTION [PHARMACOSMOS THERAPEUTICS INC.]12Current NDC, Legacy NDC, 2 package rows20240920_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MonoferricFERRIC DERISOMALTOSEPharmacosmos Therapeutics Inc.55859d2d-0456-4fa9-b41f-f535accc97db2025-11-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 208171
application number: NDA208171
ndc (package): 73594-9310-1
ndc (product): 73594-9310
ndc11 (package): 73594931001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2274398ferric derisomaltose 100 MG in 1 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
2274408ferric derisomaltose 1000 MG in 10 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
2274406ferric derisomaltose 500 MG in 5 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
2274403MonoFerric 100 MG in 1 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
2274409MonoFerric 1000 MG in 10 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
2274407MonoFerric 500 MG in 5 ML InjectionPSN55859d2d-0456-4fa9-b41f-f535accc97db13
22744031 ML ferric derisomaltose 100 MG/ML Injection [Monoferric]SBD55859d2d-0456-4fa9-b41f-f535accc97db13
227440910 ML ferric derisomaltose 100 MG/ML Injection [Monoferric]SBD55859d2d-0456-4fa9-b41f-f535accc97db13
22744075 ML ferric derisomaltose 100 MG/ML Injection [Monoferric]SBD55859d2d-0456-4fa9-b41f-f535accc97db13
22743981 ML ferric derisomaltose 100 MG/ML InjectionSCD55859d2d-0456-4fa9-b41f-f535accc97db13
227440810 ML ferric derisomaltose 100 MG/ML InjectionSCD55859d2d-0456-4fa9-b41f-f535accc97db13
22744065 ML ferric derisomaltose 100 MG/ML InjectionSCD55859d2d-0456-4fa9-b41f-f535accc97db13
22744031 ML Monoferric 100 MG/ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
227440910 ML Monoferric 100 MG/ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
22744075 ML Monoferric 100 MG/ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274398ferric derisomaltose 100 MG per 1 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274408ferric derisomaltose 1000 MG per 10 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274406ferric derisomaltose 500 MG per 5 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274403Monoferric 100 MG per 1 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274409Monoferric 1000 MG per 10 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13
2274407Monoferric 500 MG per 5 ML InjectionSY55859d2d-0456-4fa9-b41f-f535accc97db13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73594-9310-1735949310011 VIAL in 1 BOX (73594-9310-1) / 10 mL in 1 VIAL1 vial2020-01-160000-00-00NoNoCurrent