CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
72189-080
11-digit product format
721890080
Labeler code
72189
Product ID
72189-080_2be81315-9d30-1301-e063-6394a90a6a84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA208170
Marketing category
ANDA
Marketing start
2020-05-13
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
72189-080-07721890080077 TABLET, FILM COATED in 1 BOTTLE (72189-080-07) 2020-05-13NoNoHistorical
72189-080-107218900801010 TABLET, FILM COATED in 1 BOTTLE (72189-080-10) 2020-05-13NoNoHistorical
72189-080-157218900801515 TABLET, FILM COATED in 1 BOTTLE (72189-080-15) 2020-05-13NoNoHistorical
72189-080-207218900802020 TABLET, FILM COATED in 1 BOTTLE (72189-080-20) 2020-05-13NoNoHistorical
72189-080-217218900802121 TABLET, FILM COATED in 1 BOTTLE (72189-080-21) 2020-05-13NoNoHistorical
72189-080-307218900803030 TABLET, FILM COATED in 1 BOTTLE (72189-080-30) 2020-05-13NoNoHistorical
72189-080-457218900804545 TABLET, FILM COATED in 1 BOTTLE (72189-080-45) 2020-05-13NoNoHistorical
72189-080-607218900806060 TABLET, FILM COATED in 1 BOTTLE (72189-080-60) 2020-05-13NoNoHistorical
72189-080-7272189008072120 TABLET, FILM COATED in 1 BOTTLE (72189-080-72) 2020-05-13NoNoHistorical
72189-080-907218900809090 TABLET, FILM COATED in 1 BOTTLE (72189-080-90) 2020-05-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CYCLOBENZAPRINE HYDROCHLORIDEDIRECT RX2025-01-17HUMAN PRESCRIPTION DRUG LABEL8