CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
71335-2686
11-digit product format
713352686
Labeler code
71335
Product ID
71335-2686_a44fe4bc-711e-420f-ad8a-973f61620c1d
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828348

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
71335-2686-1CYCLOBENZAPRINE HYDROCHLORIDE5 in 1 BOTTLETABLET, FILM COATED52
71335-2686-2CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED102
71335-2686-3CYCLOBENZAPRINE HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED212

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNdc3cc6b6-c692-4986-8ff7-3a6cd8c85cb22
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDdc3cc6b6-c692-4986-8ff7-3a6cd8c85cb22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2686-1713352686015 TABLET, FILM COATED in 1 BOTTLE (71335-2686-1) 2025-09-18NoNoHistorical
71335-2686-27133526860210 TABLET, FILM COATED in 1 BOTTLE (71335-2686-2) 2025-09-18NoNoHistorical
71335-2686-37133526860321 TABLET, FILM COATED in 1 BOTTLE (71335-2686-3) 2025-09-18NoNoHistorical