FDA.reportPublic FDA data

Cyclobenzaprine HCL

Product NDC
80425-0016
11-digit product format
804250016
Labeler code
80425
Product ID
80425-0016_2a985779-947a-6d0e-e063-6294a90aa2a7
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
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
80425-0016-1Cyclobenzaprine HCL60 in 1 BOTTLETABLET, FILM COATED609
80425-0016-2Cyclobenzaprine HCL30 in 1 BOTTLETABLET, FILM COATED309
80425-0016-3Cyclobenzaprine HCL90 in 1 BOTTLETABLET, FILM COATED909
80425-0016-4Cyclobenzaprine HCL120 in 1 BOTTLETABLET, FILM COATED1209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0016-1EA - Each80425-0016553b5f4f-98c3-412b-becd-97fa84f9445112023-03-13
80425-0016-2EA - Each80425-0016fe471193-8819-43eb-88db-2bc0724a7bd312023-03-13
80425-0016-3EA - Each80425-0016820b6eaa-987b-4e93-815e-c755aa14355b12023-03-13
80425-0016-4EA - Each80425-0016916a100b-1077-409a-8f91-67bd1ab8d97b12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0016CYCLOBENZAPRINE HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 4 package rows20250101_afca1267-4d8f-7453-e053-2995a90a865c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNafca1267-4d8f-7453-e053-2995a90a865c9
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDafca1267-4d8f-7453-e053-2995a90a865c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0016-18042500160160 TABLET, FILM COATED in 1 BOTTLE (80425-0016-1) 2017-05-310000-00-00NoNoCurrent
80425-0016-28042500160230 TABLET, FILM COATED in 1 BOTTLE (80425-0016-2) 2017-05-310000-00-00NoNoCurrent
80425-0016-38042500160390 TABLET, FILM COATED in 1 BOTTLE (80425-0016-3) 2017-05-310000-00-00NoNoCurrent
80425-0016-480425001604120 TABLET, FILM COATED in 1 BOTTLE (80425-0016-4) 2017-05-310000-00-00NoNoCurrent