CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
71335-1099
11-digit product format
713351099
Labeler code
71335
Product ID
71335-1099_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
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
71335-1099-071335109900100 TABLET, FILM COATED in 1 BOTTLE (71335-1099-0) 2019-02-22NoNoHistorical
71335-1099-17133510990130 TABLET, FILM COATED in 1 BOTTLE (71335-1099-1) 2019-02-22NoNoHistorical
71335-1099-27133510990290 TABLET, FILM COATED in 1 BOTTLE (71335-1099-2) 2019-02-22NoNoHistorical
71335-1099-37133510990321 TABLET, FILM COATED in 1 BOTTLE (71335-1099-3) 2019-02-22NoNoHistorical
71335-1099-47133510990410 TABLET, FILM COATED in 1 BOTTLE (71335-1099-4) 2019-02-22NoNoHistorical
71335-1099-57133510990515 TABLET, FILM COATED in 1 BOTTLE (71335-1099-5) 2019-02-22NoNoHistorical
71335-1099-67133510990640 TABLET, FILM COATED in 1 BOTTLE (71335-1099-6) 2019-02-22NoNoHistorical
71335-1099-77133510990760 TABLET, FILM COATED in 1 BOTTLE (71335-1099-7) 2019-02-22NoNoHistorical
71335-1099-87133510990820 TABLET, FILM COATED in 1 BOTTLE (71335-1099-8) 2019-02-22NoNoHistorical
71335-1099-971335109909120 TABLET, FILM COATED in 1 BOTTLE (71335-1099-9) 2019-02-22NoNoHistorical

Related DailyMed Labels

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