Cyclobenzaprine hydrochloride

Product NDC
68071-2471
11-digit product format
680712471
Labeler code
68071
Product ID
68071-2471_136a6ad3-3965-ca75-e063-6394a90a15f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA213324
Marketing category
ANDA
Marketing start
2020-07-06
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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
68071-2471-16807124710115 TABLET, FILM COATED in 1 BOTTLE (68071-2471-1) 2021-07-07NoNoHistorical
68071-2471-26807124710220 TABLET, FILM COATED in 1 BOTTLE (68071-2471-2) 2021-07-07NoNoHistorical
68071-2471-76807124710721 TABLET, FILM COATED in 1 BOTTLE (68071-2471-7) 2024-03-11NoNoHistorical
68071-2471-96807124710990 TABLET, FILM COATED in 1 BOTTLE (68071-2471-9) 2021-07-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cyclobenzaprine hydrochloride Tablets, USPNuCare Pharmaceuticals,Inc.2024-03-11HUMAN PRESCRIPTION DRUG LABEL3