FDA.reportPublic FDA data

Cyclophosphamide

Product NDC
55150-271
11-digit product format
551500271
Labeler code
55150
Product ID
55150-271_f90b3bb0-87cd-4951-9789-34202e2b13df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
NDA210735
Marketing category
NDA
Marketing start
2021-08-25
Substance
CYCLOPHOSPHAMIDE
Active strength
1 g/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
CYCLOPHOSPHAMIDE1 g/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8N3DW7272P
Rxcui2386859, 2568661, 2568663

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
fbc3d08d-10bd-4e59-b59d-d530aede5badProduct name120220308
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-271-01Cyclophosphamide5 mL in 1 VIAL, SINGLE-DOSEINJECTION55
55150-271-01Cyclophosphamide1 in 1 CARTONINJECTION15
55150-271-99Cyclophosphamide5 mL in 1 VIAL, MULTI-DOSEINJECTION55
55150-271-99Cyclophosphamide1 in 1 CARTONINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-271-01ML - Milliliter55150-271f28585e7-1350-4aa4-85e9-d7f54b35355212021-10-08
55150-271-99ML - Milliliter55150-271031f1ab2-49a0-4f39-bf1c-afb43dd1c2a612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-271CYCLOPHOSPHAMIDE INJECTION [EUGIA US LLC]5Current NDC, Legacy NDC, 4 package rows20250425_3c1eb470-0bba-457d-94e3-b9508f0d398a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2568661cycloPHOSphamide 1 G in 5 ML InjectionPSN3c1eb470-0bba-457d-94e3-b9508f0d398a5
2386859cycloPHOSphamide 200 MG/ML Injectable SolutionPSN3c1eb470-0bba-457d-94e3-b9508f0d398a5
2568663cycloPHOSphamide 500 MG in 2.5 ML InjectionPSN3c1eb470-0bba-457d-94e3-b9508f0d398a5
25686632.5 ML cyclophosphamide 200 MG/ML InjectionSCD3c1eb470-0bba-457d-94e3-b9508f0d398a5
25686615 ML cyclophosphamide 200 MG/ML InjectionSCD3c1eb470-0bba-457d-94e3-b9508f0d398a5
2386859cyclophosphamide 200 MG/ML Injectable SolutionSCD3c1eb470-0bba-457d-94e3-b9508f0d398a5
2568661cyclophosphamide 1 G per 5 ML InjectionSY3c1eb470-0bba-457d-94e3-b9508f0d398a5
2568663cyclophosphamide 500 MG per 2.5 ML InjectionSY3c1eb470-0bba-457d-94e3-b9508f0d398a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-271-01551500271011 VIAL, SINGLE-DOSE in 1 CARTON (55150-271-01) > 5 mL in 1 VIAL, SINGLE-DOSE2021-08-250000-00-00NoNoCurrent
55150-271-99551500271991 VIAL, MULTI-DOSE in 1 CARTON (55150-271-99) / 5 mL in 1 VIAL, MULTI-DOSE2023-11-20NoNoCurrent