Cyclobenzaprine Hydrochloride

Product NDC
71335-0096
11-digit product format
713350096
Labeler code
71335
Product ID
71335-0096_74ade2d7-286b-45e1-ad98-19c4235d4c7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299

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
71335-0096-0Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED1011
71335-0096-1Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6011
71335-0096-2Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
71335-0096-3Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9011
71335-0096-4Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED12011
71335-0096-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED1511
71335-0096-6Cyclobenzaprine Hydrochloride45 in 1 BOTTLETABLET, FILM COATED4511
71335-0096-7Cyclobenzaprine Hydrochloride9 in 1 BOTTLETABLET, FILM COATED911
71335-0096-8Cyclobenzaprine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED18011
71335-0096-9Cyclobenzaprine Hydrochloride14 in 1 BOTTLETABLET, FILM COATED1411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0096-1EA - Each71335-0096ca937206-2159-433c-8227-a65fc8daf4ab12018-04-19
71335-0096-2EA - Each71335-0096dd441c02-40fc-4e32-80d3-8c46794b3dc212018-05-09
71335-0096-3EA - Each71335-0096c1674327-6287-4a7b-856d-cc0f46f475d812018-04-19
71335-0096-4EA - Each71335-00961196792a-e710-4fbc-b7cc-91b47edaece012018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0096CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 10 package rows20240821_59f31ca3-1b28-4768-bb29-520f06f4a9f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN59f31ca3-1b28-4768-bb29-520f06f4a9f511
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD59f31ca3-1b28-4768-bb29-520f06f4a9f511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0096-07133500960010 TABLET, FILM COATED in 1 BOTTLE (71335-0096-0) 2022-03-090000-00-00NoNoCurrent
71335-0096-17133500960160 TABLET, FILM COATED in 1 BOTTLE (71335-0096-1) 2018-03-200000-00-00NoNoCurrent
71335-0096-27133500960230 TABLET, FILM COATED in 1 BOTTLE (71335-0096-2) 2018-03-050000-00-00NoNoCurrent
71335-0096-37133500960390 TABLET, FILM COATED in 1 BOTTLE (71335-0096-3) 2018-03-200000-00-00NoNoCurrent
71335-0096-471335009604120 TABLET, FILM COATED in 1 BOTTLE (71335-0096-4) 2018-05-090000-00-00NoNoCurrent
71335-0096-57133500960515 TABLET, FILM COATED in 1 BOTTLE (71335-0096-5) 2019-09-270000-00-00NoNoCurrent
71335-0096-67133500960645 TABLET, FILM COATED in 1 BOTTLE (71335-0096-6) 2022-03-090000-00-00NoNoCurrent
71335-0096-7713350096079 TABLET, FILM COATED in 1 BOTTLE (71335-0096-7) 2018-09-040000-00-00NoNoCurrent
71335-0096-871335009608180 TABLET, FILM COATED in 1 BOTTLE (71335-0096-8) 2022-03-090000-00-00NoNoCurrent
71335-0096-97133500960914 TABLET, FILM COATED in 1 BOTTLE (71335-0096-9) 2018-04-230000-00-00NoNoCurrent