Cyclobenzaprine Hydrochloride

Product NDC
63629-1209
11-digit product format
636291209
Labeler code
63629
Product ID
63629-1209_32a1c44f-c38a-4dda-921f-cb5dec0571c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077797
Marketing category
ANDA
Marketing start
2017-03-30
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
63629-1209-1636291209011000 TABLET, FILM COATED in 1 BOTTLE (63629-1209-1) 2021-01-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx onlyBryant Ranch Prepack2023-02-27HUMAN PRESCRIPTION DRUG LABEL102