Cyclophosphamide

Product NDC
62332-618
11-digit product format
623320618
Labeler code
62332
Product ID
62332-618_c4d00f29-b259-4ba5-933b-3908870376d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclophosphamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215892
Marketing category
ANDA
Marketing start
2022-11-23
Substance
CYCLOPHOSPHAMIDE
Active strength
25 mg/1
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
CYCLOPHOSPHAMIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8N3DW7272P
Rxcui1437968, 1437969

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
62332-618-31Cyclophosphamide100 in 1 BOTTLECAPSULE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-618CYCLOPHOSPHAMIDE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 1 package rows20241225_3d6e68b1-5120-4cbb-a9d2-fb09d1b74ea1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437968cycloPHOSphamide 25 MG Oral CapsulePSN3d6e68b1-5120-4cbb-a9d2-fb09d1b74ea15
1437969cycloPHOSphamide 50 MG Oral CapsulePSN3d6e68b1-5120-4cbb-a9d2-fb09d1b74ea15
1437968cyclophosphamide 25 MG Oral CapsuleSCD3d6e68b1-5120-4cbb-a9d2-fb09d1b74ea15
1437969cyclophosphamide 50 MG Oral CapsuleSCD3d6e68b1-5120-4cbb-a9d2-fb09d1b74ea15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-618-3162332061831100 CAPSULE in 1 BOTTLE (62332-618-31) 100 capsule2022-11-230000-00-00NoNoCurrent