FDA.reportPublic FDA data

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

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 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
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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEFEROXAMINE MESYLATEACTIVE INGREDIENTV9TKO7EO6KDEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]11
DEFEROXAMINEACTIVE MOIETYJ06Y7MXW4DDEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]11

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

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