Cyclophosphamide

Product NDC
68001-442
11-digit product format
680010442
Labeler code
68001
Product ID
68001-442_4a9e24ce-e6fc-6f07-e063-6394a90ab4bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
BluePoint Laboratories
Application
ANDA040745
Marketing category
ANDA
Marketing start
2020-10-19
Substance
CYCLOPHOSPHAMIDE
Active strength
500 mg/25mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOPHOSPHAMIDE500 mg/25mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-442-26Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
68001-442-26Cyclophosphamide25 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-442CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20250406_d7e97b99-83db-42d0-8521-b87fe6467a67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSNd7e97b99-83db-42d0-8521-b87fe6467a674
1734921cycloPHOSphamide 2 GM InjectionPSNd7e97b99-83db-42d0-8521-b87fe6467a674
1734917cycloPHOSphamide 500 MG InjectionPSNd7e97b99-83db-42d0-8521-b87fe6467a674
1734919cyclophosphamide 1000 MG InjectionSCDd7e97b99-83db-42d0-8521-b87fe6467a674
1734921cyclophosphamide 2000 MG InjectionSCDd7e97b99-83db-42d0-8521-b87fe6467a674
1734917cyclophosphamide 500 MG InjectionSCDd7e97b99-83db-42d0-8521-b87fe6467a674
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSYd7e97b99-83db-42d0-8521-b87fe6467a674
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSYd7e97b99-83db-42d0-8521-b87fe6467a674
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSYd7e97b99-83db-42d0-8521-b87fe6467a674
1734919cyclophosphamide 1 GM InjectionSYd7e97b99-83db-42d0-8521-b87fe6467a674
1734921cyclophosphamide 2 GM InjectionSYd7e97b99-83db-42d0-8521-b87fe6467a674

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-442-26680010442261 VIAL, SINGLE-DOSE in 1 CARTON (68001-442-26) / 25 mL in 1 VIAL, SINGLE-DOSE2020-10-190000-00-00NoNoCurrent