FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
70121-1238
11-digit product format
701211238
Labeler code
70121
Product ID
70121-1238_40ce8341-9b51-4187-920b-ad9cce7930e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210046
Marketing category
ANDA
Marketing start
2018-05-31
Substance
CYCLOPHOSPHAMIDE
Active strength
500 mg/25mL
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
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
70121-1238-1Cyclophosphamide25 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION2513
70121-1238-1Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1238-1EA - Each70121-12389d08b9de-d46e-4841-849b-a8e78ba3c11712018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1238CYCLOPHOSPHAMIDE INJECTION, POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]10Current NDC, Legacy NDC, 2 package rows20241207_520bfe39-dfd5-4a20-9a37-80078afded0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734919cycloPHOSphamide 1 GM InjectionPSN520bfe39-dfd5-4a20-9a37-80078afded0d13
1734921cycloPHOSphamide 2 GM InjectionPSN520bfe39-dfd5-4a20-9a37-80078afded0d13
1734917cycloPHOSphamide 500 MG InjectionPSN520bfe39-dfd5-4a20-9a37-80078afded0d13
1734919cyclophosphamide 1000 MG InjectionSCD520bfe39-dfd5-4a20-9a37-80078afded0d13
1734921cyclophosphamide 2000 MG InjectionSCD520bfe39-dfd5-4a20-9a37-80078afded0d13
1734917cyclophosphamide 500 MG InjectionSCD520bfe39-dfd5-4a20-9a37-80078afded0d13
1734919cyclophosphamide (as cyclophosphamide monohydrate) 1000 MG InjectionSY520bfe39-dfd5-4a20-9a37-80078afded0d13
1734921cyclophosphamide (as cyclophosphamide monohydrate) 2000 MG InjectionSY520bfe39-dfd5-4a20-9a37-80078afded0d13
1734917cyclophosphamide (as cyclophosphamide monohydrate) 500 MG InjectionSY520bfe39-dfd5-4a20-9a37-80078afded0d13
1734919cyclophosphamide 1 GM InjectionSY520bfe39-dfd5-4a20-9a37-80078afded0d13
1734921cyclophosphamide 2 GM InjectionSY520bfe39-dfd5-4a20-9a37-80078afded0d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70121-1238-1701211238011 VIAL, SINGLE-DOSE in 1 CARTON (70121-1238-1) / 25 mL in 1 VIAL, SINGLE-DOSE2018-05-310000-00-00NoNoCurrent