Cyclobenzaprine Hydrochloride

Product NDC
76420-599
11-digit product format
764200599
Labeler code
76420
Product ID
76420-599_04ab2bbb-1be5-1bfc-e063-6394a90a103e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA078643
Marketing category
ANDA
Marketing start
2008-09-26
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
76420-599-02764200599022 TABLET, FILM COATED in 1 BOTTLE (76420-599-02) 2023-09-02NoNoHistorical
76420-599-05764200599055 TABLET, FILM COATED in 1 BOTTLE (76420-599-05) 2023-09-02NoNoHistorical
76420-599-07764200599077 TABLET, FILM COATED in 1 BOTTLE (76420-599-07) 2023-09-02NoNoHistorical
76420-599-1076420059910100 TABLET, FILM COATED in 1 BOTTLE (76420-599-10) 2023-09-02NoNoHistorical
76420-599-147642005991414 TABLET, FILM COATED in 1 BOTTLE (76420-599-14) 2023-09-02NoNoHistorical
76420-599-207642005992020 TABLET, FILM COATED in 1 BOTTLE (76420-599-20) 2023-09-02NoNoHistorical
76420-599-307642005993030 TABLET, FILM COATED in 1 BOTTLE (76420-599-30) 2023-09-02NoNoHistorical
76420-599-607642005996060 TABLET, FILM COATED in 1 BOTTLE (76420-599-60) 2023-09-02NoNoHistorical
76420-599-907642005999090 TABLET, FILM COATED in 1 BOTTLE (76420-599-90) 2023-09-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cyclobenzaprine Hydrochloride Tablets, USP Rx onlyAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2023-09-06HUMAN PRESCRIPTION DRUG LABEL1