Cyclobenzaprine Hydrochloride

Product NDC
69306-015
11-digit product format
693060015
Labeler code
69306
Product ID
69306-015_3df3e06d-9fe0-2b90-e063-6294a90ab5af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Doc Rx
Application
NDA021777
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-03-04
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
15 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 HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828358

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
69306-015-03Cyclobenzaprine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828358cyclobenzaprine HCl 15 MG 24HR Extended Release Oral CapsulePSNd4457b8c-fff8-4c19-8d5a-a667161e54461
82835824 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral CapsuleSCDd4457b8c-fff8-4c19-8d5a-a667161e54461
828358cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYd4457b8c-fff8-4c19-8d5a-a667161e54461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69306-015-036930600150330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69306-015-03) 2025-09-04NoNoHistorical