Ifosfamide

Product NDC
63323-142
11-digit product format
633230142
Labeler code
63323
Product ID
63323-142_8f166a04-4395-4ea1-8eda-98274f1bfec3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IFOSFAMIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA076078
Marketing category
ANDA
Marketing start
2003-01-28
Substance
IFOSFAMIDE
Active strength
1 g/1
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IFOSFAMIDE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUM20QQM95Y
Rxcui1791593

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f69a53e-f307-eac5-6db4-e38306b396ceProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-142-10Ifosfamide1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,15
63323-142-10Ifosfamide1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-142-10EA - Each63323-14242101e82-492c-418b-8aae-95920101841512012-07-24
63323-142-12EA - Each63323-1427ffc3879-a3f6-4c26-8e03-502bcbe90d9d12014-02-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-142IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20241019_a311a947-7b78-4226-bfe0-f4aa0be20e27.zip
63323-142IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC20241019_fb7f49af-ffe9-4969-a69c-8ed14dd0616b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791593ifosfamide 1 GM InjectionPSNa311a947-7b78-4226-bfe0-f4aa0be20e275
1791593ifosfamide 1000 MG InjectionSCDa311a947-7b78-4226-bfe0-f4aa0be20e275
1791593ifosfamide 1 GM InjectionSYa311a947-7b78-4226-bfe0-f4aa0be20e275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-142-10633230142101 VIAL, SINGLE-DOSE in 1 BOX (63323-142-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2003-01-280000-00-00NoNoCurrent
63323-142-12633230142121 VIAL, SINGLE-DOSE in 1 BOX (63323-142-12) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2003-01-280000-00-00NoNoCurrent