FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
83634-207
11-digit product format
836340207
Labeler code
83634
Product ID
83634-207_fd5fc06c-b5e5-4e07-acdb-26e56bfa2c7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
Avenacy, LLC
Application
ANDA218644
Marketing category
ANDA
Marketing start
2026-02-01
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
83634-207-51Cyclophosphamide100 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION1001
83634-207-51Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN1de02105-9c5b-4d11-bddf-bf8450d88b781
1734921cycloPHOSphamide 2 GM InjectionPSN1de02105-9c5b-4d11-bddf-bf8450d88b781
1734917cycloPHOSphamide 500 MG InjectionPSN1de02105-9c5b-4d11-bddf-bf8450d88b781
1734919cyclophosphamide 1000 MG InjectionSCD1de02105-9c5b-4d11-bddf-bf8450d88b781
1734921cyclophosphamide 2000 MG InjectionSCD1de02105-9c5b-4d11-bddf-bf8450d88b781
1734917cyclophosphamide 500 MG InjectionSCD1de02105-9c5b-4d11-bddf-bf8450d88b781
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY1de02105-9c5b-4d11-bddf-bf8450d88b781
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY1de02105-9c5b-4d11-bddf-bf8450d88b781
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY1de02105-9c5b-4d11-bddf-bf8450d88b781
1734919cyclophosphamide 1 GM InjectionSY1de02105-9c5b-4d11-bddf-bf8450d88b781
1734921cyclophosphamide 2 GM InjectionSY1de02105-9c5b-4d11-bddf-bf8450d88b781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83634-207-51836340207511 VIAL, SINGLE-DOSE in 1 CARTON (83634-207-51) / 100 mL in 1 VIAL, SINGLE-DOSE2026-02-01NoNoCurrent