FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
72189-283
11-digit product format
721890283
Labeler code
72189
Product ID
72189-283_2c292ad7-a15f-7642-e063-6394a90a18b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRx
Application
ANDA208170
Marketing category
ANDA
Marketing start
2021-10-19
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
72189-283-15CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED159
72189-283-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED209
72189-283-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED309
72189-283-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED609
72189-283-82CYCLOBENZAPRINE HYDROCHLORIDE180 in 1 BOTTLETABLET, FILM COATED1809
72189-283-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-283CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECTRX]9Current NDC, Legacy NDC, 6 package rows20250121_ceb56ab8-4a76-6dee-e053-2995a90aab30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNceb56ab8-4a76-6dee-e053-2995a90aab309
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDceb56ab8-4a76-6dee-e053-2995a90aab309

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-283-157218902831515 TABLET, FILM COATED in 1 BOTTLE (72189-283-15) 2021-10-19NoNoCurrent
72189-283-207218902832020 TABLET, FILM COATED in 1 BOTTLE (72189-283-20) 2021-10-190000-00-00NoNoCurrent
72189-283-307218902833030 TABLET, FILM COATED in 1 BOTTLE (72189-283-30) 2021-10-190000-00-00NoNoCurrent
72189-283-607218902836060 TABLET, FILM COATED in 1 BOTTLE (72189-283-60) 2021-10-190000-00-00NoNoCurrent
72189-283-8272189028382180 TABLET, FILM COATED in 1 BOTTLE (72189-283-82) 2021-10-19NoNoCurrent
72189-283-907218902839090 TABLET, FILM COATED in 1 BOTTLE (72189-283-90) 2021-10-190000-00-00NoNoCurrent