FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
68001-695
11-digit product format
680010695
Labeler code
68001
Product ID
68001-695_4cd3801f-1a1a-33fd-e063-6294a90aa2b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
BluePoint Laboratories
Application
ANDA218644
Marketing category
ANDA
Marketing start
2026-03-15
Substance
CYCLOPHOSPHAMIDE
Active strength
1 g/50mL
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-695-32Cyclophosphamide50 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION501
68001-695-32Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-695-32EA - Each68001-69536e6353d-53ea-4097-aa56-e8235ce7dff012026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN1d3396d8-4c03-4a28-890a-d87c6c53a74e1
1734921cycloPHOSphamide 2 GM InjectionPSN1d3396d8-4c03-4a28-890a-d87c6c53a74e1
1734917cycloPHOSphamide 500 MG InjectionPSN1d3396d8-4c03-4a28-890a-d87c6c53a74e1
1734919cyclophosphamide 1000 MG InjectionSCD1d3396d8-4c03-4a28-890a-d87c6c53a74e1
1734921cyclophosphamide 2000 MG InjectionSCD1d3396d8-4c03-4a28-890a-d87c6c53a74e1
1734917cyclophosphamide 500 MG InjectionSCD1d3396d8-4c03-4a28-890a-d87c6c53a74e1
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY1d3396d8-4c03-4a28-890a-d87c6c53a74e1
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY1d3396d8-4c03-4a28-890a-d87c6c53a74e1
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY1d3396d8-4c03-4a28-890a-d87c6c53a74e1
1734919cyclophosphamide 1 GM InjectionSY1d3396d8-4c03-4a28-890a-d87c6c53a74e1
1734921cyclophosphamide 2 GM InjectionSY1d3396d8-4c03-4a28-890a-d87c6c53a74e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-695-32680010695321 VIAL, SINGLE-DOSE in 1 CARTON (68001-695-32) / 50 mL in 1 VIAL, SINGLE-DOSE2026-03-15NoNoHistorical