Cyclobenzaprine HCL

Product NDC
80425-0017
11-digit product format
804250017
Labeler code
80425
Product ID
80425-0017_2a982dd7-c533-0a5b-e063-6294a90aafd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA077563
Marketing category
ANDA
Marketing start
2006-04-04
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
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 HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320

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
80425-0017-1Cyclobenzaprine HCL60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0017-1EA - Each80425-0017491a6f20-f080-42a3-a5d9-b83a2b908e2e12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0017CYCLOBENZAPRINE HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 1 package rows20250101_afca2a49-6424-7b6a-e053-2a95a90ad41e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNafca2a49-6424-7b6a-e053-2a95a90ad41e5
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDafca2a49-6424-7b6a-e053-2a95a90ad41e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0017-18042500170160 TABLET, FILM COATED in 1 BOTTLE (80425-0017-1) 2006-04-040000-00-00NoNoCurrent