CYCLOPHOSPHAMIDE

Product NDC
10019-945
11-digit product format
100190945
Labeler code
10019
Product ID
10019-945_3d950615-927d-441e-b3be-0cebda594df5
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
10019-945-01CYCLOPHOSPHAMIDE1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION115
10019-945-10CYCLOPHOSPHAMIDE100 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-945-01EA - Each10019-945e826b885-7703-4c0e-b5f7-8d2f2344c57812015-01-05
10019-945-10EA - Each10019-94549cb011b-5686-43a3-a7fc-067aa0bd584b12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOPHOSPHAMIDEACTIVE INGREDIENT8N3DW7272PCYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]2
CYCLOPHOSPHAMIDE ANHYDROUSACTIVE MOIETY6UXW23996MCYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-945CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]13Current NDC, Legacy NDC, 2 package rows20250519_cef038cc-efab-46d9-99c2-95bb11d6c9bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSNcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734921cycloPHOSphamide 2 GM InjectionPSNcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734917cycloPHOSphamide 500 MG InjectionPSNcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734919cyclophosphamide 1000 MG InjectionSCDcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734921cyclophosphamide 2000 MG InjectionSCDcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734917cyclophosphamide 500 MG InjectionSCDcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSYcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSYcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSYcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734919cyclophosphamide 1 GM InjectionSYcef038cc-efab-46d9-99c2-95bb11d6c9bc15
1734921cyclophosphamide 2 GM InjectionSYcef038cc-efab-46d9-99c2-95bb11d6c9bc15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10019-945-01100190945011 VIAL, SINGLE-DOSE in 1 CARTON (10019-945-01) / 100 mL in 1 VIAL, SINGLE-DOSE (10019-945-10) 2008-05-210000-00-00NoNoCurrent
10019-945-1010019094510100 mL in 1 VIAL, SINGLE-DOSE100 mlHistorical