FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
80425-0019
11-digit product format
804250019
Labeler code
80425
Product ID
80425-0019_2a9878c8-a142-224c-e063-6394a90a839d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA077797
Marketing category
ANDA
Marketing start
2017-03-30
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 Hydrochloride
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
80425-0019-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
80425-0019-2Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED607
80425-0019-3Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0019-1EA - Each80425-0019a20142c5-13a3-4a37-b419-1a54479f013512023-03-13
80425-0019-2EA - Each80425-00199a65bbc6-bb48-4af5-85bd-25bc19fac09512023-03-13
80425-0019-3EA - Each80425-0019f4aa8e45-e1e1-444b-afd5-13cf3235436712023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0019CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_afcad582-ab59-4f70-e053-2a95a90a04e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNafcad582-ab59-4f70-e053-2a95a90a04e47
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDafcad582-ab59-4f70-e053-2a95a90a04e47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0019-18042500190130 TABLET, FILM COATED in 1 BOTTLE (80425-0019-1) 2017-03-300000-00-00NoNoCurrent
80425-0019-28042500190260 TABLET, FILM COATED in 1 BOTTLE (80425-0019-2) 2017-03-300000-00-00NoNoCurrent
80425-0019-38042500190390 TABLET, FILM COATED in 1 BOTTLE (80425-0019-3) 2017-03-300000-00-00NoNoCurrent