Cyclobenzaprine hydrochloride

Product NDC
50090-5711
11-digit product format
500905711
Labeler code
50090
Product ID
50090-5711_22a3e440-266d-4a3e-a1fe-6df83fea6abd
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
50090-5711-05009057110015 TABLET, FILM COATED in 1 BOTTLE (50090-5711-0) 2021-09-24NoNoHistorical
50090-5711-15009057110120 TABLET, FILM COATED in 1 BOTTLE (50090-5711-1) 2021-09-24NoNoHistorical
50090-5711-25009057110230 TABLET, FILM COATED in 1 BOTTLE (50090-5711-2) 2021-09-24NoNoHistorical
50090-5711-35009057110360 TABLET, FILM COATED in 1 BOTTLE (50090-5711-3) 2021-09-24NoNoHistorical
50090-5711-450090571104100 TABLET, FILM COATED in 1 BOTTLE (50090-5711-4) 2021-09-24NoNoHistorical
50090-5711-6500905711067 TABLET, FILM COATED in 1 BOTTLE (50090-5711-6) 2021-09-24NoNoHistorical
50090-5711-75009057110714 TABLET, FILM COATED in 1 BOTTLE (50090-5711-7) 2021-09-24NoNoHistorical
50090-5711-85009057110821 TABLET, FILM COATED in 1 BOTTLE (50090-5711-8) 2021-09-24NoNoHistorical
50090-5711-95009057110910 TABLET, FILM COATED in 1 BOTTLE (50090-5711-9) 2021-09-24NoNoHistorical

Related DailyMed Labels

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