FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiV9TKO7EO6K
Rxcui1731345, 1731350

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

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