FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
14335-470
11-digit product format
143350470
Labeler code
14335
Product ID
14335-470_2aca7731-9fcc-4625-e063-6394a90a6020
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide for Injection
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA218632
Marketing category
ANDA
Marketing start
2025-01-03
Substance
CYCLOPHOSPHAMIDE
Active strength
500 mg/25mL
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
CYCLOPHOSPHAMIDE500 mg/25mL

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
14335-470-01Cyclophosphamide25 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION251
14335-470-10Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-470CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE FOR INJECTION) INJECTION, POWDER, FOR SOLUTION [HAINAN POLY PHARM. CO., LTD.]1Current NDC, 2 package rows20250104_6fde2705-a2d8-4d48-9618-b9d99d051373.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN6fde2705-a2d8-4d48-9618-b9d99d0513731
1734921cycloPHOSphamide 2 GM InjectionPSN6fde2705-a2d8-4d48-9618-b9d99d0513731
1734917cycloPHOSphamide 500 MG InjectionPSN6fde2705-a2d8-4d48-9618-b9d99d0513731
1734919cyclophosphamide 1000 MG InjectionSCD6fde2705-a2d8-4d48-9618-b9d99d0513731
1734921cyclophosphamide 2000 MG InjectionSCD6fde2705-a2d8-4d48-9618-b9d99d0513731
1734917cyclophosphamide 500 MG InjectionSCD6fde2705-a2d8-4d48-9618-b9d99d0513731
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY6fde2705-a2d8-4d48-9618-b9d99d0513731
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY6fde2705-a2d8-4d48-9618-b9d99d0513731
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY6fde2705-a2d8-4d48-9618-b9d99d0513731
1734919cyclophosphamide 1 GM InjectionSY6fde2705-a2d8-4d48-9618-b9d99d0513731
1734921cyclophosphamide 2 GM InjectionSY6fde2705-a2d8-4d48-9618-b9d99d0513731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14335-470-011433504700125 mL in 1 VIAL, SINGLE-DOSE25 mlHistorical
14335-470-10143350470101 VIAL, SINGLE-DOSE in 1 CARTON (14335-470-10) / 25 mL in 1 VIAL, SINGLE-DOSE (14335-470-01) 2025-01-03NoNoHistorical