Cyclophosphamide

Product NDC
70301-2013
11-digit product format
703012013
Labeler code
70301
Product ID
70301-2013_5100a9aa-5e4b-1edb-e063-6294a90a174e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOPHOSPHAMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
OPKO Pharmaceuticals, LLC
Application
ANDA218282
Marketing category
ANDA
Marketing start
2026-04-20
Substance
CYCLOPHOSPHAMIDE
Active strength
25 mg/1
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
CYCLOPHOSPHAMIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8N3DW7272P
Rxcui1437968

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
70301-2013-1Cyclophosphamide100 in 1 BOTTLECAPSULE1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437968cycloPHOSphamide 25 MG Oral CapsulePSNd8057d1a-e8af-42ab-9da2-b545730b26551
1437968cyclophosphamide 25 MG Oral CapsuleSCDd8057d1a-e8af-42ab-9da2-b545730b26551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70301-2013-170301201301100 CAPSULE in 1 BOTTLE (70301-2013-1) 100 capsule2026-04-20NoNoHistorical