CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
71335-1266
11-digit product format
713351266
Labeler code
71335
Product ID
71335-1266_e1d36423-2d90-4161-933c-86e83e8c14a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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

Additional Listing Data

Finished product
Yes
Brand name base
CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration
2026-12-31

Related Records

Active Ingredients

IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers

FieldValues
Unii0VE05JYS2P
Rxcui828320, 828348

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1266-07133512660040 TABLET, FILM COATED in 1 BOTTLE (71335-1266-0) 2019-07-110000-00-00NoNoCurrent
71335-1266-17133512660114 TABLET, FILM COATED in 1 BOTTLE (71335-1266-1) 2019-07-110000-00-00NoNoCurrent
71335-1266-27133512660284 TABLET, FILM COATED in 1 BOTTLE (71335-1266-2) 2019-07-110000-00-00NoNoCurrent
71335-1266-37133512660330 TABLET, FILM COATED in 1 BOTTLE (71335-1266-3) 2019-07-110000-00-00NoNoCurrent
71335-1266-47133512660420 TABLET, FILM COATED in 1 BOTTLE (71335-1266-4) 2019-07-110000-00-00NoNoCurrent
71335-1266-57133512660515 TABLET, FILM COATED in 1 BOTTLE (71335-1266-5) 2019-07-110000-00-00NoNoCurrent
71335-1266-67133512660660 TABLET, FILM COATED in 1 BOTTLE (71335-1266-6) 2019-07-110000-00-00NoNoCurrent
71335-1266-77133512660790 TABLET, FILM COATED in 1 BOTTLE (71335-1266-7) 2019-07-110000-00-00NoNoCurrent
71335-1266-87133512660856 TABLET, FILM COATED in 1 BOTTLE (71335-1266-8) 2019-07-110000-00-00NoNoCurrent
71335-1266-971335126609120 TABLET, FILM COATED in 1 BOTTLE (71335-1266-9) 2019-07-110000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cyclobenzaprine hydrochloride, USPBryant Ranch Prepack2023-10-18HUMAN PRESCRIPTION DRUG LABEL4