CYCLOPHOSPHAMIDE

Product NDC
50742-519
11-digit product format
507420519
Labeler code
50742
Product ID
50742-519_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
2020-07-30
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-519-02ML - Milliliter50742-5199a3569d6-4918-4ccd-b8ce-0706ab5c808f12020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-519-02507420519021 VIAL in 1 CARTON (50742-519-02) > 2.5 mL in 1 VIAL1 vial2020-07-310000-00-00NoNoCurrent