Insulin Glargine

Product NDC
49502-394
11-digit product format
495020394
Labeler code
49502
Product ID
49502-394_a14de887-e390-4d3f-8863-48ca77969e2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glargine-yfgn
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Mylan Specialty L.P.
Application
BLA761201
Marketing category
BLA
Marketing start
2021-11-16
Marketing end
0000-00-00
Substance
INSULIN GLARGINE
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin [CS],Insulin Analog [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49502-394-71ML - Milliliter49502-39413f54672-5b68-45ba-82bc-9ef1608971fa12021-11-09
49502-394-75ML - Milliliter49502-394c6c7cd70-be13-4c39-a934-30423d481e7b12021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49502-394-75495020394755 SYRINGE in 1 CARTON (49502-394-75) > 3 mL in 1 SYRINGE (49502-394-71) 5 syringe2021-11-160000-00-00NoNoCurrent