FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
71335-1266
11-digit product format
713351266
Labeler code
71335
Product ID
71335-1266_e1d36423-2d90-4161-933c-86e83e8c14a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320, 828348

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1266-0CYCLOBENZAPRINE HYDROCHLORIDE40 in 1 BOTTLETABLET, FILM COATED404
71335-1266-1CYCLOBENZAPRINE HYDROCHLORIDE14 in 1 BOTTLETABLET, FILM COATED144
71335-1266-2CYCLOBENZAPRINE HYDROCHLORIDE84 in 1 BOTTLETABLET, FILM COATED844
71335-1266-3CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED304
71335-1266-4CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED204
71335-1266-5CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED154
71335-1266-6CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED604
71335-1266-7CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED904
71335-1266-8CYCLOBENZAPRINE HYDROCHLORIDE56 in 1 BOTTLETABLET, FILM COATED564
71335-1266-9CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1266-1EA - Each71335-1266860b3952-ff07-4b83-b619-56dfe873ded012019-10-07
71335-1266-3EA - Each71335-12665bfb9165-0ddd-4890-8d12-2f4923a50d5a12019-10-07
71335-1266-4EA - Each71335-12664e23c496-89dd-454b-a65d-c2aa34bea03212019-10-07
71335-1266-5EA - Each71335-126637d8e114-b8a3-486b-8a83-635b1f1ce57312019-10-07
71335-1266-6EA - Each71335-1266f8c852d2-6034-47c8-9cee-a9e6e051468d12019-10-07
71335-1266-7EA - Each71335-12665626ae51-f54c-40de-b4f1-9793d2a90a0712019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1266CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20231019_85128989-bfa3-4b82-94c1-f90b14ccd2f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN85128989-bfa3-4b82-94c1-f90b14ccd2f94
828320cyclobenzaprine HCl 5 MG Oral TabletPSN85128989-bfa3-4b82-94c1-f90b14ccd2f94
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD85128989-bfa3-4b82-94c1-f90b14ccd2f94
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD85128989-bfa3-4b82-94c1-f90b14ccd2f94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1266-07133512660040 TABLET, FILM COATED in 1 BOTTLE (71335-1266-0) 2019-07-110000-00-00NoNoCurrent
71335-1266-17133512660114 TABLET, FILM COATED in 1 BOTTLE (71335-1266-1) 2019-07-110000-00-00NoNoCurrent
71335-1266-27133512660284 TABLET, FILM COATED in 1 BOTTLE (71335-1266-2) 2019-07-110000-00-00NoNoCurrent
71335-1266-37133512660330 TABLET, FILM COATED in 1 BOTTLE (71335-1266-3) 2019-07-110000-00-00NoNoCurrent
71335-1266-47133512660420 TABLET, FILM COATED in 1 BOTTLE (71335-1266-4) 2019-07-110000-00-00NoNoCurrent
71335-1266-57133512660515 TABLET, FILM COATED in 1 BOTTLE (71335-1266-5) 2019-07-110000-00-00NoNoCurrent
71335-1266-67133512660660 TABLET, FILM COATED in 1 BOTTLE (71335-1266-6) 2019-07-110000-00-00NoNoCurrent
71335-1266-77133512660790 TABLET, FILM COATED in 1 BOTTLE (71335-1266-7) 2019-07-110000-00-00NoNoCurrent
71335-1266-87133512660856 TABLET, FILM COATED in 1 BOTTLE (71335-1266-8) 2019-07-110000-00-00NoNoCurrent
71335-1266-971335126609120 TABLET, FILM COATED in 1 BOTTLE (71335-1266-9) 2019-07-110000-00-00NoNoCurrent