FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
10019-957
11-digit product format
100190957
Labeler code
10019
Product ID
10019-957_a466e63c-d425-4387-a41f-d1cd8023f694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
Baxter Healthcare Company
Application
ANDA040745
Marketing category
ANDA
Marketing start
2008-05-21
Substance
CYCLOPHOSPHAMIDE
Active strength
2 g/100mL
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
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
10019-957-01Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION120
10019-957-11Cyclophosphamide100 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-957-01EA - Each10019-957c56cf082-114f-4fd5-a012-e2a56e5e8b0212012-07-24
10019-957-11EA - Each10019-9579bb2aa93-39c3-4617-a8c2-216ee2fe689912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOPHOSPHAMIDEACTIVE INGREDIENT8N3DW7272PCYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]5
CYCLOPHOSPHAMIDE ANHYDROUSACTIVE MOIETY6UXW23996MCYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-957CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]17Current NDC, Legacy NDC, 2 package rows20250114_591d9955-3d9c-4cdc-a308-2f1288376b9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN591d9955-3d9c-4cdc-a308-2f1288376b9f20
1734921cycloPHOSphamide 2 GM InjectionPSN591d9955-3d9c-4cdc-a308-2f1288376b9f20
1734917cycloPHOSphamide 500 MG InjectionPSN591d9955-3d9c-4cdc-a308-2f1288376b9f20
1734919cyclophosphamide 1000 MG InjectionSCD591d9955-3d9c-4cdc-a308-2f1288376b9f20
1734921cyclophosphamide 2000 MG InjectionSCD591d9955-3d9c-4cdc-a308-2f1288376b9f20
1734917cyclophosphamide 500 MG InjectionSCD591d9955-3d9c-4cdc-a308-2f1288376b9f20
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY591d9955-3d9c-4cdc-a308-2f1288376b9f20
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY591d9955-3d9c-4cdc-a308-2f1288376b9f20
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY591d9955-3d9c-4cdc-a308-2f1288376b9f20
1734919cyclophosphamide 1 GM InjectionSY591d9955-3d9c-4cdc-a308-2f1288376b9f20
1734921cyclophosphamide 2 GM InjectionSY591d9955-3d9c-4cdc-a308-2f1288376b9f20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10019-957-01100190957011 VIAL, SINGLE-DOSE in 1 CARTON (10019-957-01) / 100 mL in 1 VIAL, SINGLE-DOSE (10019-957-11) 2008-05-210000-00-00NoNoCurrent
10019-957-1110019095711100 mL in 1 VIAL, SINGLE-DOSE100 mlHistorical