Cyclobenzaprine Hydrochloride

Product NDC
58118-0846
11-digit product format
581180846
Labeler code
58118
Product ID
58118-0846_b024cbe4-c6ec-5e4b-e053-2995a90a5ebb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA090478
Marketing category
ANDA
Marketing start
2016-07-22
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0846-82024-01-30C16284748780-11030e365-0a34-111a-e063-dadaa90a10e21f47b8e0-24a5-4651-896f-189ee80ff6bd

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0846CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]4Legacy NDC20200926_1f47b8e0-24a5-4651-896f-189ee80ff6bd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-0846-85811808460830 TABLET, FILM COATED in 1 BLISTER PACK (58118-0846-8) 2018-08-270000-00-00NoNoCurrent