Cyclobenzaprine hydrochloride

Product NDC
50090-5712
11-digit product format
500905712
Labeler code
50090
Product ID
50090-5712_39b5ac79-ad9a-4b68-ac00-f28408f7d31d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213324
Marketing category
ANDA
Marketing start
2020-07-06
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
50090-5712-0500905712003 TABLET, FILM COATED in 1 BOTTLE (50090-5712-0) 2021-09-24NoNoHistorical
50090-5712-15009057120112 TABLET, FILM COATED in 1 BOTTLE (50090-5712-1) 2021-09-24NoNoHistorical
50090-5712-45009057120442 TABLET, FILM COATED in 1 BOTTLE (50090-5712-4) 2021-09-24NoNoHistorical
50090-5712-8500905712086 TABLET, FILM COATED in 1 BOTTLE (50090-5712-8) 2021-09-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cyclobenzaprine hydrochloride Tablets, USPA-S Medication Solutions2025-11-19HUMAN PRESCRIPTION DRUG LABEL8