CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
71205-356
11-digit product format
712050356
Labeler code
71205
Product ID
71205-356_b8f42c39-b984-478f-a2b8-97209a356960
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
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
71205-356-157120503561515 TABLET, FILM COATED in 1 BOTTLE (71205-356-15) 2021-07-20NoNoHistorical
71205-356-207120503562020 TABLET, FILM COATED in 1 BOTTLE (71205-356-20) 2023-04-06NoNoHistorical
71205-356-217120503562121 TABLET, FILM COATED in 1 BOTTLE (71205-356-21) 2023-04-06NoNoHistorical
71205-356-307120503563030 TABLET, FILM COATED in 1 BOTTLE (71205-356-30) 2019-11-01NoNoHistorical
71205-356-407120503564040 TABLET, FILM COATED in 1 BOTTLE (71205-356-40) 2024-01-08NoNoHistorical
71205-356-607120503566060 TABLET, FILM COATED in 1 BOTTLE (71205-356-60) 2019-11-01NoNoHistorical
71205-356-907120503569090 TABLET, FILM COATED in 1 BOTTLE (71205-356-90) 2019-11-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cyclobenzaprine hydrochloride, USPProficient Rx LP2024-01-01HUMAN PRESCRIPTION DRUG LABEL5