Cyclobenzaprine Hydrochloride

Product NDC
53149-4841
11-digit product format
531494841
Labeler code
53149
Product ID
53149-4841_d6652f0c-2b9b-46a0-bc6a-6118865d1d0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
All Pharma, LLC
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
53149-4841-92020-01-31C16284748780-19d75b9d0-5ee1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-4841-9Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-4841CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ALL PHARMA, LLC]2Legacy NDC, 1 package rows20160308_48d950cf-dd93-4333-90eb-f519b9590de3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN48d950cf-dd93-4333-90eb-f519b9590de32
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD48d950cf-dd93-4333-90eb-f519b9590de32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53149-4841-95314948410990 in 1 BOTTLEHistorical