FDA.reportPublic FDA data

CYCLOPHOSPHAMIDE

Product NDC
39822-0255
11-digit product format
398220255
Labeler code
39822
Product ID
39822-0255_29b88d00-eeea-7282-e063-6294a90a4024
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA211757
Marketing category
ANDA
Marketing start
2023-12-19
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
39822-0255-1CYCLOPHOSPHAMIDE50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,504
39822-0255-1CYCLOPHOSPHAMIDE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0255-1EA - Each39822-0255da9293a1-2af2-4027-8bfc-63d46e2077b312024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-0255CYCLOPHOSPHAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]4Current NDC, 2 package rows20241222_02e64046-687d-449e-e063-6294a90a6c32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN02e64046-687d-449e-e063-6294a90a6c324
1734921cycloPHOSphamide 2 GM InjectionPSN02e64046-687d-449e-e063-6294a90a6c324
1734917cycloPHOSphamide 500 MG InjectionPSN02e64046-687d-449e-e063-6294a90a6c324
1734919cyclophosphamide 1000 MG InjectionSCD02e64046-687d-449e-e063-6294a90a6c324
1734921cyclophosphamide 2000 MG InjectionSCD02e64046-687d-449e-e063-6294a90a6c324
1734917cyclophosphamide 500 MG InjectionSCD02e64046-687d-449e-e063-6294a90a6c324
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY02e64046-687d-449e-e063-6294a90a6c324
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY02e64046-687d-449e-e063-6294a90a6c324
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY02e64046-687d-449e-e063-6294a90a6c324
1734919cyclophosphamide 1 GM InjectionSY02e64046-687d-449e-e063-6294a90a6c324
1734921cyclophosphamide 2 GM InjectionSY02e64046-687d-449e-e063-6294a90a6c324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
39822-0255-1398220255011 VIAL, SINGLE-DOSE in 1 CARTON (39822-0255-1) / 50 mL in 1 VIAL, SINGLE-DOSE2023-12-19NoNoCurrent