Deferoxamine mesylate

Product NDC
68083-172
11-digit product format
680830172
Labeler code
68083
Product ID
68083-172_316b7751-fbd4-4b19-b7b7-701554fd3b21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferoxamine mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Gland Pharma Limited
Application
ANDA207384
Marketing category
ANDA
Marketing start
2017-10-09
Substance
DEFEROXAMINE MESYLATE
Active strength
500 mg/1
Pharmacologic classes
Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
68083-172-01Deferoxamine mesylate4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-172DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]5Current NDC, Legacy NDC, 1 package rows20240608_598fba68-f46e-4b6e-894c-63c2940b2063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731345deferoxamine mesylate 2 GM InjectionPSN598fba68-f46e-4b6e-894c-63c2940b20636
1731350deferoxamine mesylate 500 MG InjectionPSN598fba68-f46e-4b6e-894c-63c2940b20636
1731345deferoxamine mesylate 2000 MG InjectionSCD598fba68-f46e-4b6e-894c-63c2940b20636
1731350deferoxamine mesylate 500 MG InjectionSCD598fba68-f46e-4b6e-894c-63c2940b20636
1731345deferoxamine mesylate 2 GM InjectionSY598fba68-f46e-4b6e-894c-63c2940b20636

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68083-172-01680830172014 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68083-172-01) 2017-10-090000-00-00NoNoCurrent