Cyclobenzaprine Hydrochloride

Product NDC
72162-1358
11-digit product format
721621358
Labeler code
72162
Product ID
72162-1358_8d5da604-8e13-492e-93d0-8f9890606e54
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
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
72162-1358-172162135801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72162-1358-1) 2023-10-03NoNoHistorical
72162-1358-572162135805500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72162-1358-5) 2023-10-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx onlyBryant Ranch Prepack2024-01-31HUMAN PRESCRIPTION DRUG LABEL101