Cyclobenzaprine Hydrochloride

Product NDC
72162-1692
11-digit product format
721621692
Labeler code
72162
Product ID
72162-1692_0208b80b-278d-4ef8-b9a2-858f77d9d789
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077563
Marketing category
ANDA
Marketing start
2006-04-04
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
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
72162-1692-0721621692001000 TABLET, FILM COATED in 1 BOTTLE (72162-1692-0) 2024-01-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cyclobenzaprine Hydrochloride Tablets Rx OnlyBryant Ranch Prepack2025-04-01HUMAN PRESCRIPTION DRUG LABEL101