Cyclobenzaprine Hydrochloride

Product NDC
71610-379
11-digit product format
716100379
Labeler code
71610
Product ID
71610-379_9868780c-c321-4d61-8250-235d502e7d7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077563
Marketing category
ANDA
Marketing start
2006-04-04
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-379-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
71610-379-45Cyclobenzaprine Hydrochloride45 in 1 BOTTLETABLET, FILM COATED451
71610-379-53Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
71610-379-60Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
71610-379-80Cyclobenzaprine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1801
71610-379-92Cyclobenzaprine Hydrochloride270 in 1 BOTTLETABLET, FILM COATED2701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-379CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 6 package rows20200125_9b4d726d-391e-4fbe-9958-baf8c638ec8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN9b4d726d-391e-4fbe-9958-baf8c638ec8f1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD9b4d726d-391e-4fbe-9958-baf8c638ec8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-379-307161003793030 TABLET, FILM COATED in 1 BOTTLE (71610-379-30) 2019-12-310000-00-00NoNoCurrent
71610-379-457161003794545 TABLET, FILM COATED in 1 BOTTLE (71610-379-45) 2019-12-310000-00-00NoNoCurrent
71610-379-537161003795360 TABLET, FILM COATED in 1 BOTTLE (71610-379-53) 2019-12-310000-00-00NoNoCurrent
71610-379-607161003796090 TABLET, FILM COATED in 1 BOTTLE (71610-379-60) 2020-01-150000-00-00NoNoCurrent
71610-379-8071610037980180 TABLET, FILM COATED in 1 BOTTLE (71610-379-80) 2019-12-310000-00-00NoNoCurrent
71610-379-9271610037992270 TABLET, FILM COATED in 1 BOTTLE (71610-379-92) 2019-12-310000-00-00NoNoCurrent