CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
50090-4729
11-digit product format
500904729
Labeler code
50090
Product ID
50090-4729_44f75da3-1fee-4928-b8eb-491d47d8bc08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE6202-23-9CYCLOBENZAPRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-4729-0500904729003 TABLET, FILM COATED in 1 BOTTLE (50090-4729-0) 2019-11-18NoNoHistorical
50090-4729-15009047290112 TABLET, FILM COATED in 1 BOTTLE (50090-4729-1) 2019-11-18NoNoHistorical
50090-4729-45009047290442 TABLET, FILM COATED in 1 BOTTLE (50090-4729-4) 2019-11-18NoNoHistorical
50090-4729-8500904729086 TABLET, FILM COATED in 1 BOTTLE (50090-4729-8) 2019-11-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cyclobenzaprine hydrochloride, USPA-S Medication Solutions2024-05-29HUMAN PRESCRIPTION DRUG LABEL6