Cyclobenzaprine Hydrochloride

Product NDC
55700-527
11-digit product format
557000527
Labeler code
55700
Product ID
55700-527_76571717-02dd-4565-afbc-03f7fa70f5c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
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
55700-527-0155700052701120 TABLET, FILM COATED in 1 BOTTLE (55700-527-01) 2017-06-070000-00-00NoNoCurrent