CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
71335-2492
11-digit product format
713352492
Labeler code
71335
Product ID
71335-2492_f4827d42-98e5-43a6-a466-ea29789cbe8a
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2492-07133524920040 TABLET, FILM COATED in 1 BOTTLE (71335-2492-0) 2025-02-03NoNoHistorical
71335-2492-17133524920114 TABLET, FILM COATED in 1 BOTTLE (71335-2492-1) 2024-09-10NoNoHistorical
71335-2492-27133524920284 TABLET, FILM COATED in 1 BOTTLE (71335-2492-2) 2025-02-03NoNoHistorical
71335-2492-37133524920330 TABLET, FILM COATED in 1 BOTTLE (71335-2492-3) 2024-09-13NoNoHistorical
71335-2492-47133524920420 TABLET, FILM COATED in 1 BOTTLE (71335-2492-4) 2024-11-26NoNoHistorical
71335-2492-57133524920515 TABLET, FILM COATED in 1 BOTTLE (71335-2492-5) 2025-02-03NoNoHistorical
71335-2492-67133524920660 TABLET, FILM COATED in 1 BOTTLE (71335-2492-6) 2024-09-09NoNoHistorical
71335-2492-77133524920790 TABLET, FILM COATED in 1 BOTTLE (71335-2492-7) 2024-09-05NoNoHistorical
71335-2492-87133524920856 TABLET, FILM COATED in 1 BOTTLE (71335-2492-8) 2025-02-03NoNoHistorical
71335-2492-971335249209120 TABLET, FILM COATED in 1 BOTTLE (71335-2492-9) 2024-10-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cyclobenzaprine hydrochloride, USPBryant Ranch Prepack2025-02-03HUMAN PRESCRIPTION DRUG LABEL2