Cyclophosphamide

Product NDC
25021-248
11-digit product format
250210248
Labeler code
25021
Product ID
25021-248_5ed11ef9-73c0-42d1-9cac-0fba10a1f991
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA214529
Marketing category
ANDA
Marketing start
2024-01-15
Substance
CYCLOPHOSPHAMIDE
Active strength
1 g/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclophosphamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOPHOSPHAMIDE1 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8N3DW7272P
Rxcui1734917, 1734919, 1734921

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0db1850b-2dc3-47a1-8b35-fab6e1685124Product name320250814
0b38b013-6fe7-0a7a-ece2-0a10ca467a97Product name420250801
f22fb018-dc36-4ffa-a765-94776b98899bProduct name120250620
e71baeca-a07a-452b-ba2b-50be55aedc79Product name220250617
913f6711-71c9-4a3d-a6d5-98cbd101b5d8Product name120231023
cd3d0a71-dbf2-4640-91f7-c99c45edfbb6Product name120231023
fbc3d08d-10bd-4e59-b59d-d530aede5badProduct name120220308
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-248-51Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
25021-248-51Cyclophosphamide50 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-248-51EA - Each25021-24874ead718-43cb-4e6e-bf2e-4228b6ee4fce12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-248CYCLOPHOSPHAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]4Current NDC, 2 package rows20250304_329b5a3a-c7b9-4b11-abf0-009719cdfb79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN329b5a3a-c7b9-4b11-abf0-009719cdfb794
1734921cycloPHOSphamide 2 GM InjectionPSN329b5a3a-c7b9-4b11-abf0-009719cdfb794
1734917cycloPHOSphamide 500 MG InjectionPSN329b5a3a-c7b9-4b11-abf0-009719cdfb794
1734919cyclophosphamide 1000 MG InjectionSCD329b5a3a-c7b9-4b11-abf0-009719cdfb794
1734921cyclophosphamide 2000 MG InjectionSCD329b5a3a-c7b9-4b11-abf0-009719cdfb794
1734917cyclophosphamide 500 MG InjectionSCD329b5a3a-c7b9-4b11-abf0-009719cdfb794
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY329b5a3a-c7b9-4b11-abf0-009719cdfb794
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY329b5a3a-c7b9-4b11-abf0-009719cdfb794
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY329b5a3a-c7b9-4b11-abf0-009719cdfb794
1734919cyclophosphamide 1 GM InjectionSY329b5a3a-c7b9-4b11-abf0-009719cdfb794
1734921cyclophosphamide 2 GM InjectionSY329b5a3a-c7b9-4b11-abf0-009719cdfb794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-248-51250210248511 VIAL in 1 CARTON (25021-248-51) / 50 mL in 1 VIAL1 vial2024-01-15NoNoCurrent