Cyclobenzaprine Hydrochloride

Product NDC
70934-383
11-digit product format
709340383
Labeler code
70934
Product ID
70934-383_af489aa8-973b-33e1-e053-2995a90ad280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA071611
Marketing category
ANDA
Marketing start
2019-06-03
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-383-06709340383066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-383-06) 2019-06-030000-00-00NoNoCurrent