Cyclobenzaprine Hydrochloride

Product NDC
0615-8182
11-digit product format
006158182
Labeler code
0615
Product ID
0615-8182_cb3fa04f-0ca1-4350-a29a-2ebe86233f64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA078048
Marketing category
ANDA
Marketing start
2014-07-31
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8182-050061581820515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8182-05) 2020-02-130000-00-00NoNoCurrent
0615-8182-390061581823930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8182-39) 2019-01-100000-00-00NoNoCurrent