FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
42806-903
11-digit product format
428060903
Labeler code
42806
Product ID
42806-903_14b3b66b-0e87-4e71-8507-e23c8214cc50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
Epic Pharma, LLC
Application
ANDA218644
Marketing category
ANDA
Marketing start
2024-06-30
Substance
CYCLOPHOSPHAMIDE
Active strength
2 g/100mL
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
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
42806-903-26Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION12
42806-903-26Cyclophosphamide100 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-903-26EA - Each42806-9033c848c20-264c-47e6-8b2b-7711cbbdbaa812025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN988d2f71-1dc7-45b5-b2df-187e682249732
1734921cycloPHOSphamide 2 GM InjectionPSN988d2f71-1dc7-45b5-b2df-187e682249732
1734917cycloPHOSphamide 500 MG InjectionPSN988d2f71-1dc7-45b5-b2df-187e682249732
1734919cyclophosphamide 1000 MG InjectionSCD988d2f71-1dc7-45b5-b2df-187e682249732
1734921cyclophosphamide 2000 MG InjectionSCD988d2f71-1dc7-45b5-b2df-187e682249732
1734917cyclophosphamide 500 MG InjectionSCD988d2f71-1dc7-45b5-b2df-187e682249732
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY988d2f71-1dc7-45b5-b2df-187e682249732
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY988d2f71-1dc7-45b5-b2df-187e682249732
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY988d2f71-1dc7-45b5-b2df-187e682249732
1734919cyclophosphamide 1 GM InjectionSY988d2f71-1dc7-45b5-b2df-187e682249732
1734921cyclophosphamide 2 GM InjectionSY988d2f71-1dc7-45b5-b2df-187e682249732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42806-903-26428060903261 VIAL, SINGLE-DOSE in 1 CARTON (42806-903-26) / 100 mL in 1 VIAL, SINGLE-DOSE2024-06-30NoNoHistorical