CYCLOPHOSPHAMIDE

Product NDC
50742-521
11-digit product format
507420521
Labeler code
50742
Product ID
50742-521_83db39e2-26c4-4971-9452-710144a389c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclophosphamide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Ingenus Pharmaceuticals, LLC
Application
NDA212501
Marketing category
NDA
Marketing start
2021-09-16
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-521-10ML - Milliliter50742-5214db37c5a-692f-4908-88c4-f3a04090f82112022-01-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-521-10507420521101 VIAL in 1 CARTON (50742-521-10) > 10 mL in 1 VIAL1 vial2021-09-160000-00-00NoNoCurrent