Cyclobenzaprine Hydrochloride

Product NDC
55700-981
11-digit product format
557000981
Labeler code
55700
Product ID
55700-981_77971f19-d9e8-4452-ad42-5ed8a9224a4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
NDA021777
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-08-09
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE6202-23-9CYCLOBENZAPRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-981-605570009816060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-981-60) 2022-08-090000-00-00NoNoCurrent