Cyclobenzaprine Hydrochloride

Product NDC
70518-3159
11-digit product format
705183159
Labeler code
70518
Product ID
70518-3159_cacba52d-2cab-f314-e053-2a95a90aaf2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090478
Marketing category
ANDA
Marketing start
2021-07-15
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3159-07051831590010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3159-0) 2021-07-150000-00-00NoNoCurrent
70518-3159-1705183159015 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3159-1) 2021-08-300000-00-00NoNoCurrent