FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
72189-280
11-digit product format
721890280
Labeler code
72189
Product ID
72189-280_4c5cd6ce-a63a-c9fd-e063-6394a90ab906
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRx
Application
ANDA213324
Marketing category
ANDA
Marketing start
2021-10-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-280-152025-01-30C16284748780-12cef2736-a958-d83d-e063-dadaa90ab31fCyclobenzaprine HCl
72189-280-302025-01-30C16284748780-12cef2736-a958-d83d-e063-dadaa90ab31fCyclobenzaprine HCl
72189-280-602025-01-30C16284748780-12cef2736-a958-d83d-e063-dadaa90ab31fCyclobenzaprine HCl
72189-280-822025-01-30C16284748780-12cef2736-a958-d83d-e063-dadaa90ab31fCyclobenzaprine HCl
72189-280-902025-01-30C16284748780-12cef2736-a958-d83d-e063-dadaa90ab31fCyclobenzaprine HCl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-280-15CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED157
72189-280-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED207
72189-280-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED307
72189-280-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED607
72189-280-82CYCLOBENZAPRINE HYDROCHLORIDE180 in 1 BOTTLETABLET, FILM COATED1807
72189-280-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-280CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECTRX]5Current NDC, Legacy NDC, 6 package rows20231212_cdc5b438-6b6b-0cdd-e053-2a95a90a7f75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNcdc5b438-6b6b-0cdd-e053-2a95a90a7f757
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDcdc5b438-6b6b-0cdd-e053-2a95a90a7f757

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-280-157218902801515 TABLET, FILM COATED in 1 BOTTLE (72189-280-15) 2021-10-07NoNoCurrent
72189-280-207218902802020 TABLET, FILM COATED in 1 BOTTLE (72189-280-20) 2021-10-07NoNoCurrent
72189-280-307218902803030 TABLET, FILM COATED in 1 BOTTLE (72189-280-30) 2021-10-070000-00-00NoNoCurrent
72189-280-607218902806060 TABLET, FILM COATED in 1 BOTTLE (72189-280-60) 2021-10-070000-00-00NoNoCurrent
72189-280-8272189028082180 TABLET, FILM COATED in 1 BOTTLE (72189-280-82) 2021-10-07NoNoCurrent
72189-280-907218902809090 TABLET, FILM COATED in 1 BOTTLE (72189-280-90) 2021-10-07NoNoCurrent