Deferoxamine mesylate

Product NDC
52609-4504
11-digit product format
526094504
Labeler code
52609
Product ID
52609-4504_cbc75c16-6c82-869c-84a8-deaa76ebdb1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferoxamine mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
ApoPharma USA, Inc.
Application
ANDA207384
Marketing category
ANDA
Marketing start
2018-03-23
Marketing end
0000-00-00
Substance
DEFEROXAMINE MESYLATE
Active strength
2 g/1
Pharmacologic classes
Iron Chelating Activity [MoA],Iron Chelator [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52609-4504-62022-01-28C16284748780-1d6a99b39-ea01-a426-e053-dadaa90af4c2Deferoxamine Mesylate for Injection, USP Vials Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52609-4504-6Deferoxamine mesylate4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52609-4504-6EA - Each52609-4504c5a59266-2f69-4652-94a4-d835a5e927e512018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52609-4504DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOPHARMA USA, INC.]1Legacy NDC, 1 package rows20180327_72348776-4971-bc49-8b66-67a2422567d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731345deferoxamine mesylate 2 GM InjectionPSN72348776-4971-bc49-8b66-67a2422567d41
1731350deferoxamine mesylate 500 MG InjectionPSN72348776-4971-bc49-8b66-67a2422567d41
1731345deferoxamine mesylate 2000 MG InjectionSCD72348776-4971-bc49-8b66-67a2422567d41
1731350deferoxamine mesylate 500 MG InjectionSCD72348776-4971-bc49-8b66-67a2422567d41
1731345deferoxamine mesylate 2 GM InjectionSY72348776-4971-bc49-8b66-67a2422567d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52609-4504-6526094504064 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (52609-4504-6) 2018-03-230000-00-00NoNoCurrent