Cyclobenzaprine Hydrochloride

Product NDC
71335-2696
11-digit product format
713352696
Labeler code
71335
Product ID
71335-2696_1c50e06b-4ca8-48f0-bfba-f3a2c2752c41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021777
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-03-04
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828353

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
71335-2696-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
71335-2696-2Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSN8a8c9479-b3ab-453a-bd8a-deaf380007421
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCD8a8c9479-b3ab-453a-bd8a-deaf380007421
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY8a8c9479-b3ab-453a-bd8a-deaf380007421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2696-17133526960130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2696-1) 2025-09-24NoNoCurrent
71335-2696-27133526960260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2696-2) 2025-09-24NoNoCurrent