Deferoxamine Mesylate

Product NDC
0409-2337
11-digit product format
004092337
Labeler code
0409
Product ID
0409-2337_0c19b646-2901-4648-a502-a226b1eb0fef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferoxamine Mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
ANDA076019
Marketing category
ANDA
Marketing start
2005-03-31
Substance
DEFEROXAMINE MESYLATE
Active strength
2 g/1
Pharmacologic classes
Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-2337DDiscontinued by firm2026-08-17
excluded packagepackage0409-23370409-2337-12DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-2337-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-2337-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-2337-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-2337-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-2337-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-2337-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-2337-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-2337-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-2337-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-2337-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-2337-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-2337-12557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076019-001DEFEROXAMINE MESYLATEDEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-17
A076019-002DEFEROXAMINE MESYLATEDEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076019-001AP
A076019-002AP

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2004-03-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076019-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2004-03-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076019-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAPRS2004-03-17bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076019-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A076019-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076019-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076019-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076019-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076019-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076019-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076019-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076019-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076019-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076019-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076019-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076019-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076019-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076019-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076019-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076019-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076019-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076019-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076019-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076019-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076019-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076019-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076019-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076019-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076019-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076019-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076019-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076019-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076019-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076019-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076019-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076019-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076019-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076019-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076019-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076019-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076019-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076019-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076019-002AP1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Deferoxamine Mesylate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFEROXAMINE MESYLATE2 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V9TKO7EO6KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1731345Internal RxNorm lookup
1731350Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9ab6b1c-98d0-4373-0e9b-b10cb4a67543Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef0d89c6-318e-9caf-5072-1f6976740df3Product name220171121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2337-15Deferoxamine Mesylate1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,127
0409-2337-25Deferoxamine Mesylate4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,427

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2337-15EA - Each0409-233729b6176d-4a84-49fc-b00d-9ad3374eed6f12021-04-08
0409-2337-25EA - Each0409-23375294fc9d-6476-45db-baf3-8d6561a7d5e512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2337DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]23Current NDC, Legacy NDC, 2 package rows20240319_f9ab6b1c-98d0-4373-0e9b-b10cb4a67543.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
Deferoxamine MesylateDEFEROXAMINE MESYLATEHospira, Inc.f9ab6b1c-98d0-4373-0e9b-b10cb4a675432026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076019
application number: ANDA076019
ndc (product): 0409-2337

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731345deferoxamine mesylate 2 GM InjectionPSNf9ab6b1c-98d0-4373-0e9b-b10cb4a6754327
1731350deferoxamine mesylate 500 MG InjectionPSNf9ab6b1c-98d0-4373-0e9b-b10cb4a6754327
1731345deferoxamine mesylate 2000 MG InjectionSCDf9ab6b1c-98d0-4373-0e9b-b10cb4a6754327
1731350deferoxamine mesylate 500 MG InjectionSCDf9ab6b1c-98d0-4373-0e9b-b10cb4a6754327
1731345deferoxamine mesylate 2 GM InjectionSYf9ab6b1c-98d0-4373-0e9b-b10cb4a6754327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-2337-15004092337151 in 1 VIAL, SINGLE-USEHistorical
0409-2337-25004092337254 VIAL, SINGLE-USE in 1 CARTON (0409-2337-25) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0409-2337-15) 2005-03-310000-00-00NoNoCurrent