Cyclobenzaprine Hydrochloride

Product NDC
70518-4174
11-digit product format
705184174
Labeler code
70518
Product ID
70518-4174_3fb97d05-7844-9fd8-e063-6394a90a495c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA021777
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-09-04
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
70518-4174-0Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4174CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]1Current NDC, 1 package rows20240906_3175d24d-e8a0-4f14-bed9-a60ad59ac7e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSN3175d24d-e8a0-4f14-bed9-a60ad59ac7e72
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCD3175d24d-e8a0-4f14-bed9-a60ad59ac7e72
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY3175d24d-e8a0-4f14-bed9-a60ad59ac7e72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4174-07051841740030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4174-0) 2024-09-04NoNoHistorical