FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
0781-3528
11-digit product format
007813528
Labeler code
0781
Product ID
0781-3528_3a7a4ad7-90ca-4d84-92f1-c61032067deb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
NDA217150
Marketing category
NDA
Marketing start
2024-04-08
Substance
CYCLOPHOSPHAMIDE
Active strength
500 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8N3DW7272P
Rxcui2679073

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
0781-3528-10Cyclophosphamide1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE13
0781-3528-75Cyclophosphamide5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION, CONCENTRATE53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3528-10ML - Milliliter0781-3528f56a3640-2bae-42db-92e2-b352828ca50d12024-05-16
0781-3528-75ML - Milliliter0781-3528c6295888-46ac-401a-b7a2-458a8e0aea4012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3528CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CONCENTRATE [SANDOZ INC]3Current NDC, 2 package rows20250228_cf2f4b95-0327-499a-a5a3-51b1bdef68c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2679073cycloPHOSphamide 100 MG/ML Injectable SolutionPSNcf2f4b95-0327-499a-a5a3-51b1bdef68c53
2679073cyclophosphamide 100 MG/ML Injectable SolutionSCDcf2f4b95-0327-499a-a5a3-51b1bdef68c53
2679073cyclophosphamide (as cyclophosphamide monohydrate) 100 MG/ML Injectable SolutionSYcf2f4b95-0327-499a-a5a3-51b1bdef68c53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-3528-10007813528101 VIAL, MULTI-DOSE in 1 CARTON (0781-3528-10) / 5 mL in 1 VIAL, MULTI-DOSE (0781-3528-75) 2024-04-08NoNoHistorical
0781-3528-75007813528755 mL in 1 VIAL, MULTI-DOSE5 mlHistorical