CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
70518-3356
11-digit product format
705183356
Labeler code
70518
Product ID
70518-3356_d89ae02c-ea15-d2df-e053-2995a90a18b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208170
Marketing category
ANDA
Marketing start
2022-02-03
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3356-07051833560020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3356-0) 2022-02-030000-00-00NoNoCurrent
70518-3356-17051833560160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3356-1) 2022-02-210000-00-00NoNoCurrent