LEVOLEUCOVORIN

Product NDC
50742-495
11-digit product format
507420495
Labeler code
50742
Product ID
50742-495_d831ccd4-d7f4-4e9e-a5aa-671df65f67e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levoleucovorin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA210623
Marketing category
ANDA
Marketing start
2018-05-08
Marketing end
0000-00-00
Substance
LEVOLEUCOVORIN CALCIUM PENTAHYDRATE
Active strength
10 mg/mL
Pharmacologic classes
Folate Analog [EPC],Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-495-25ML - Milliliter50742-4953114c14c-7b09-47e7-82ad-248ef7f1d17112018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-495-25507420495251 VIAL in 1 CARTON (50742-495-25) > 25 mL in 1 VIAL1 vial2018-05-080000-00-00NoNoCurrent