Cyclobenzaprine Hydrochloride

Product NDC
72789-073
11-digit product format
727890073
Labeler code
72789
Product ID
72789-073_340442be-1fd5-2781-e063-6294a90a4f8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077797
Marketing category
ANDA
Marketing start
2017-03-30
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
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
72789-073-307278900733030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-073-30) 2020-04-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx onlyPD-Rx Pharmaceuticals, Inc.2025-04-30HUMAN PRESCRIPTION DRUG LABEL9