Insulin Glargine

Product NDC
49502-393
11-digit product format
495020393
Labeler code
49502
Product ID
49502-393_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
49502-393-80ML - Milliliter49502-3938d0d1a2d-b693-4d3d-96c4-1de9a075e10412021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49502-393-80495020393801 VIAL, MULTI-DOSE in 1 CARTON (49502-393-80) > 10 mL in 1 VIAL, MULTI-DOSE2021-11-160000-00-00NoNoCurrent