Deferoxamine mesylate

Product NDC
60505-6236
11-digit product format
605056236
Labeler code
60505
Product ID
60505-6236_afafa387-54f4-e492-fea1-1872742d6674
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferoxamine mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Apotex Corp.
Application
ANDA207384
Marketing category
ANDA
Marketing start
2021-11-05
Substance
DEFEROXAMINE MESYLATE
Active strength
500 mg/1
Pharmacologic classes
Iron Chelating Activity [MoA], Iron Chelator [EPC]
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 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
A207384-001DEFEROXAMINE MESYLATEDEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-29
A207384-002DEFEROXAMINE MESYLATEDEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207384-001AP
A207384-002AP

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 06:07:402026-07A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207384-001DEFEROXAMINE MESYLATE500MG/VIALINJECTABLE / INJECTIONAP2017-09-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207384-002DEFEROXAMINE MESYLATE2GM/VIALINJECTABLE / INJECTIONAP2017-09-29bb7c543d1eb4…

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 06:07:402026-07A207384-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207384-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207384-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207384-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207384-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207384-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207384-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207384-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207384-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207384-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207384-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207384-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207384-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207384-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207384-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207384-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207384-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207384-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207384-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207384-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207384-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207384-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207384-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207384-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207384-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207384-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207384-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207384-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207384-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207384-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207384-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207384-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207384-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207384-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207384-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207384-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207384-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207384-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207384-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207384-002AP1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFEROXAMINE MESYLATE500 mg/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
c99553fb-3fae-b88a-6c2c-efa7520197f9Available 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
60505-6236-6Deferoxamine mesylate4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6236-6EA - Each60505-6236e82d0a7d-9791-4383-a8e6-8421a3e8f4ce12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6236DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP.]4Current NDC, Legacy NDC, 1 package rows20240926_c99553fb-3fae-b88a-6c2c-efa7520197f9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Deferoxamine mesylateDEFEROXAMINE MESYLATEApotex Corp.c99553fb-3fae-b88a-6c2c-efa7520197f92026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207384
application number: ANDA207384
ndc (product): 60505-6236
Deferoxamine mesylateDEFEROXAMINE MESYLATEGland Pharma Limited598fba68-f46e-4b6e-894c-63c2940b20632026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207384
application number: ANDA207384

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731345deferoxamine mesylate 2 GM InjectionPSNc99553fb-3fae-b88a-6c2c-efa7520197f97
1731350deferoxamine mesylate 500 MG InjectionPSNc99553fb-3fae-b88a-6c2c-efa7520197f97
1731345deferoxamine mesylate 2000 MG InjectionSCDc99553fb-3fae-b88a-6c2c-efa7520197f97
1731350deferoxamine mesylate 500 MG InjectionSCDc99553fb-3fae-b88a-6c2c-efa7520197f97
1731345deferoxamine mesylate 2 GM InjectionSYc99553fb-3fae-b88a-6c2c-efa7520197f97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6236-6605056236064 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (60505-6236-6) 2021-11-050000-00-00NoNoCurrent