Baclofen

Product NDC
0615-8412
11-digit product format
006158412
Labeler code
0615
Product ID
0615-8412_09957659-c9d6-4c07-afaf-0776f750b94d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA077971
Marketing category
ANDA
Marketing start
2007-10-27
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
20 mg/1
Pharmacologic classes
GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8412-390061584123930 TABLET in 1 BLISTER PACK (0615-8412-39) 30 tablet2021-10-280000-00-00NoNoCurrent