Cyclobenzaprine Hydrochloride

Product NDC
63629-2424
11-digit product format
636292424
Labeler code
63629
Product ID
63629-2424_fb9eb346-51bf-4091-ab5b-56b40c763077
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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 Hydrochloride
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
63629-2424-1Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED1000103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2424-1EA - Each63629-2424819b0228-986c-422b-86aa-a0187cacb12a12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2424CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20250323_dcef9b63-f998-4852-920d-c356623cea6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNdcef9b63-f998-4852-920d-c356623cea6a103
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDdcef9b63-f998-4852-920d-c356623cea6a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2424-1636292424011000 TABLET, FILM COATED in 1 BOTTLE (63629-2424-1) 2021-02-250000-00-00NoNoCurrent