FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
80425-0547
11-digit product format
804250547
Labeler code
80425
Product ID
80425-0547_3bddfe25-00bb-747f-e063-6394a90a9ce6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA077563
Marketing category
ANDA
Marketing start
2025-08-08
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
80425-0547-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
80425-0547-2Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
80425-0547-3Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0547-1EA - Each80425-05477945519a-f39d-46d3-b223-ef90f81c9a9312025-09-12
80425-0547-2EA - Each80425-0547e4e67a22-574e-4ca8-b897-9f52b648143312025-09-12
80425-0547-3EA - Each80425-0547ee2c02ef-a9b8-426c-bd90-e3e1bdb5eeea12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN3bddfe25-00ba-747f-e063-6394a90a9ce61
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD3bddfe25-00ba-747f-e063-6394a90a9ce61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0547-18042505470130 TABLET, FILM COATED in 1 BOTTLE (80425-0547-1) 2025-08-08NoNoHistorical
80425-0547-28042505470260 TABLET, FILM COATED in 1 BOTTLE (80425-0547-2) 2025-08-08NoNoHistorical
80425-0547-38042505470390 TABLET, FILM COATED in 1 BOTTLE (80425-0547-3) 2025-08-08NoNoHistorical