Cyclobenzaprine Hydrochloride

Product NDC
71205-132
11-digit product format
712050132
Labeler code
71205
Product ID
71205-132_5650efcf-e609-43b2-868f-03d375fcd7b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078722
Marketing category
ANDA
Marketing start
2018-01-16
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-132-20EA - Each71205-13213eb6dcb-87fc-4d27-a570-de2273c1a94012019-01-24
71205-132-60EA - Each71205-1322fb11c4c-5887-4001-a28f-8179f309bd5012018-11-06
71205-132-72EA - Each71205-132e29d6c1c-317f-412e-831c-76d46da8d71d12019-09-05
71205-132-90EA - Each71205-13241fe5fb7-9829-475b-b260-7de05722763912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-132CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]5Legacy NDC20201031_10f568d1-caaa-4474-8728-242085da3cfd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-132-207120501322020 TABLET, FILM COATED in 1 BOTTLE (71205-132-20) 2019-01-010000-00-00NoNoCurrent
71205-132-307120501323030 TABLET, FILM COATED in 1 BOTTLE (71205-132-30) 2018-10-010000-00-00NoNoCurrent
71205-132-607120501326060 TABLET, FILM COATED in 1 BOTTLE (71205-132-60) 2018-10-010000-00-00NoNoCurrent
71205-132-7271205013272120 TABLET, FILM COATED in 1 BOTTLE (71205-132-72) 2018-10-010000-00-00NoNoCurrent
71205-132-7871205013278180 TABLET, FILM COATED in 1 BOTTLE (71205-132-78) 2018-10-010000-00-00NoNoCurrent
71205-132-907120501329090 TABLET, FILM COATED in 1 BOTTLE (71205-132-90) 2018-10-010000-00-00NoNoCurrent