Cyclophosphamide

Product NDC
72572-083
11-digit product format
725720083
Labeler code
72572
Product ID
72572-083_053f9d6f-8818-41f3-856d-7816bc7e35be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
Civica, Inc.
Application
ANDA040745
Marketing category
ANDA
Marketing start
2008-05-21
Substance
CYCLOPHOSPHAMIDE
Active strength
2 g/100mL
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
CYCLOPHOSPHAMIDE2 g/100mL

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
72572-083-01Cyclophosphamide100 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION1009
72572-083-01Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-083-01EA - Each72572-0832be64d46-bc9d-42d4-a225-aedeb90af46b12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-083CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [CIVICA, INC.]6Current NDC, Legacy NDC, 2 package rows20250309_8627c83f-c057-495d-9f78-8b67bda97b3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN8627c83f-c057-495d-9f78-8b67bda97b3e9
1734921cycloPHOSphamide 2 GM InjectionPSN8627c83f-c057-495d-9f78-8b67bda97b3e9
1734917cycloPHOSphamide 500 MG InjectionPSN8627c83f-c057-495d-9f78-8b67bda97b3e9
1734919cyclophosphamide 1000 MG InjectionSCD8627c83f-c057-495d-9f78-8b67bda97b3e9
1734921cyclophosphamide 2000 MG InjectionSCD8627c83f-c057-495d-9f78-8b67bda97b3e9
1734917cyclophosphamide 500 MG InjectionSCD8627c83f-c057-495d-9f78-8b67bda97b3e9
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY8627c83f-c057-495d-9f78-8b67bda97b3e9
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY8627c83f-c057-495d-9f78-8b67bda97b3e9
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY8627c83f-c057-495d-9f78-8b67bda97b3e9
1734919cyclophosphamide 1 GM InjectionSY8627c83f-c057-495d-9f78-8b67bda97b3e9
1734921cyclophosphamide 2 GM InjectionSY8627c83f-c057-495d-9f78-8b67bda97b3e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72572-083-01725720083011 VIAL, SINGLE-DOSE in 1 CARTON (72572-083-01) / 100 mL in 1 VIAL, SINGLE-DOSE2022-12-140000-00-00NoNoCurrent