Cyclophosphamide

Product NDC
14789-126
11-digit product format
147890126
Labeler code
14789
Product ID
14789-126_4e548b5c-d8d1-0f7a-e063-6294a90ae76e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Nexus Pharmaceuticals, LLC
Application
ANDA216783
Marketing category
ANDA
Marketing start
2026-03-30
Substance
CYCLOPHOSPHAMIDE
Active strength
200 mg/mL
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
CYCLOPHOSPHAMIDE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8N3DW7272P
Rxcui2386859

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
14789-126-05Cyclophosphamide1 in 1 CARTONINJECTION17
14789-126-07Cyclophosphamide5 mL in 1 VIAL, GLASSINJECTION57

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2386859cycloPHOSphamide 200 MG/ML Injectable SolutionPSNc961a1ac-6705-4756-9abc-9d84a6fcb5c87
2386859cyclophosphamide 200 MG/ML Injectable SolutionSCDc961a1ac-6705-4756-9abc-9d84a6fcb5c87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14789-126-05147890126051 VIAL, GLASS in 1 CARTON (14789-126-05) / 5 mL in 1 VIAL, GLASS (14789-126-07) 2026-03-30NoNoCurrent
14789-126-07147890126075 mL in 1 VIAL, GLASS5 mlHistorical