CYCLOPHOSPHAMIDE

Product NDC
68001-563
11-digit product format
680010563
Labeler code
68001
Product ID
68001-563_ee393ea3-02cb-a8d7-e053-2995a90a3963
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
NDA212501
Marketing category
NDA
Marketing start
2022-11-30
Marketing end
0000-00-00
Substance
CYCLOPHOSPHAMIDE ANHYDROUS
Active strength
200 mg/mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-563-84CYCLOPHOSPHAMIDE2.5 mL in 1 VIALINJECTION, SOLUTION2.57
68001-563-84CYCLOPHOSPHAMIDE1 in 1 CARTONINJECTION, SOLUTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-563CYCLOPHOSPHAMIDE INJECTION, SOLUTION [BLUEPOINT LABORATORIES]6Legacy NDC, 2 package rows20241122_0afd2cc7-09e6-481a-afea-9d2e3742da46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2386859cycloPHOSphamide 200 MG/ML Injectable SolutionPSN0afd2cc7-09e6-481a-afea-9d2e3742da467
2386859cyclophosphamide 200 MG/ML Injectable SolutionSCD0afd2cc7-09e6-481a-afea-9d2e3742da467

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-563-84680010563841 VIAL in 1 CARTON (68001-563-84) > 2.5 mL in 1 VIAL1 vial2022-11-300000-00-00NoNoCurrent