FDA.reportPublic FDA data

Cyclobenzaprine HCL

Product NDC
80425-0018
11-digit product format
804250018
Labeler code
80425
Product ID
80425-0018_2a985a04-15cf-b8b6-e063-6394a90a4231
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
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
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 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
80425-0018-1Cyclobenzaprine HCL30 in 1 BOTTLETABLET, FILM COATED308
80425-0018-2Cyclobenzaprine HCL60 in 1 BOTTLETABLET, FILM COATED608
80425-0018-3Cyclobenzaprine HCL90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0018-1EA - Each80425-00184b64f1c0-c241-4839-b0e1-a721173296d812023-03-13
80425-0018-2EA - Each80425-00180b1b8bdf-7a8d-4901-b71b-da92a9ceb5d012023-03-13
80425-0018-3EA - Each80425-001871405b22-828e-47c4-939a-69cdf17fde8312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0018CYCLOBENZAPRINE HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 3 package rows20250101_afcab35f-4ab9-33a4-e053-2a95a90ad529.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNafcab35f-4ab9-33a4-e053-2a95a90ad5298
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDafcab35f-4ab9-33a4-e053-2a95a90ad5298

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0018-18042500180130 TABLET, FILM COATED in 1 BOTTLE (80425-0018-1) 2017-05-310000-00-00NoNoCurrent
80425-0018-28042500180260 TABLET, FILM COATED in 1 BOTTLE (80425-0018-2) 2017-05-310000-00-00NoNoCurrent
80425-0018-38042500180390 TABLET, FILM COATED in 1 BOTTLE (80425-0018-3) 2017-05-310000-00-00NoNoCurrent