Cyclobenzaprine

Product NDC
53149-4842
11-digit product format
531494842
Labeler code
53149
Product ID
53149-4842_a5d66602-d6fb-47a6-9bb7-6640e5b56555
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
All Pharma, LLC
Application
ANDA071611
Marketing category
ANDA
Marketing start
2016-10-18
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-4842-1Cyclobenzaprine120 in 1 BOTTLETABLET, FILM COATED1205
53149-4842-3Cyclobenzaprine30 in 1 BOTTLETABLET, FILM COATED305
53149-4842-6Cyclobenzaprine60 in 1 BOTTLETABLET, FILM COATED605
53149-4842-9Cyclobenzaprine90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-4842CYCLOBENZAPRINE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [ALL PHARMA, LLC]5Legacy NDC, 4 package rows20181213_f40e92bb-c86b-4634-9bba-9fa4616aba82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNf40e92bb-c86b-4634-9bba-9fa4616aba825
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDf40e92bb-c86b-4634-9bba-9fa4616aba825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53149-4842-153149484201120 in 1 BOTTLEHistorical
53149-4842-35314948420330 in 1 BOTTLEHistorical
53149-4842-65314948420660 in 1 BOTTLEHistorical
53149-4842-95314948420990 in 1 BOTTLEHistorical