Cyclobenzaprine Hydrochloride

Product NDC
63629-9297
11-digit product format
636299297
Labeler code
63629
Product ID
63629-9297_958fe57f-bd10-4ea9-bbf5-fa2a045574d7
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
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
63629-9297-1636299297011000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9297-1) 2022-06-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx onlyBryant Ranch Prepack2024-01-15HUMAN PRESCRIPTION DRUG LABEL101