Fexmid

Product NDC
53149-4851
11-digit product format
531494851
Labeler code
53149
Product ID
53149-4851_07435db6-6f06-49f8-abd2-96b20df94807
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
2011-10-01
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
53149-4851-1Fexmid120 in 1 BOTTLETABLET, FILM COATED1202
53149-4851-3Fexmid30 in 1 BOTTLETABLET, FILM COATED302
53149-4851-6Fexmid60 in 1 BOTTLETABLET, FILM COATED602
53149-4851-9Fexmid90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-4851FEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [ALL PHARMA, LLC]2Legacy NDC, 4 package rows20180814_edb9de54-2dff-4442-8136-644cf500db95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNedb9de54-2dff-4442-8136-644cf500db952
828301Fexmid 7.5 MG Oral TabletPSNedb9de54-2dff-4442-8136-644cf500db952
828301cyclobenzaprine hydrochloride 7.5 MG Oral Tablet [Fexmid]SBDedb9de54-2dff-4442-8136-644cf500db952
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDedb9de54-2dff-4442-8136-644cf500db952
828301Fexmid 7.5 MG Oral TabletSYedb9de54-2dff-4442-8136-644cf500db952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53149-4851-153149485101120 in 1 BOTTLEHistorical
53149-4851-35314948510330 in 1 BOTTLEHistorical
53149-4851-65314948510660 in 1 BOTTLEHistorical
53149-4851-95314948510990 in 1 BOTTLEHistorical