FDA.reportPublic FDA data

Fexmid

Product NDC
50436-0950
11-digit product format
504360950
Labeler code
50436
Product ID
50436-0950_7175311c-a773-40ac-80df-cc71fed6f2a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0950-12020-01-31C16284748780-19d75b9d0-f34f-f424-e053-dadaa90a57ceFexmid ® 7.5 mg cyclobenzaprine HCl Tablets USP Revised: October 2014 Rx only 184152-3
50436-0950-22020-01-31C16284748780-19d75b9d0-f34f-f424-e053-dadaa90a57ceFexmid ® 7.5 mg cyclobenzaprine HCl Tablets USP Revised: October 2014 Rx only 184152-3
50436-0950-32020-01-31C16284748780-19d75b9d0-f34f-f424-e053-dadaa90a57ceFexmid ® 7.5 mg cyclobenzaprine HCl Tablets USP Revised: October 2014 Rx only 184152-3
50436-0950-42020-01-31C16284748780-19d75b9d0-f34f-f424-e053-dadaa90a57ceFexmid ® 7.5 mg cyclobenzaprine HCl Tablets USP Revised: October 2014 Rx only 184152-3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0950-1Fexmid30 in 1 BOTTLETABLET, FILM COATED302
50436-0950-2Fexmid60 in 1 BOTTLETABLET, FILM COATED602
50436-0950-3Fexmid90 in 1 BOTTLETABLET, FILM COATED902
50436-0950-4Fexmid120 in 1 BOTTLETABLET, FILM COATED1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0950-1EA - Each50436-095052ce8346-0a33-4333-8859-2f3f021ea48112018-01-12
50436-0950-2EA - Each50436-0950e652c06f-0938-4f1d-827f-e46f3147a5e512018-01-12
50436-0950-3EA - Each50436-09509a1ae7d1-604d-47ac-a833-dcd7852ff7f612018-01-12
50436-0950-4EA - Each50436-09503fdb70c1-c565-4eca-bfe2-b716b6cc9cc912018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0950FEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 4 package rows20171215_a948b6b2-ced1-4f7a-a098-2c2e369c3ce3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNa948b6b2-ced1-4f7a-a098-2c2e369c3ce32
828301Fexmid 7.5 MG Oral TabletPSNa948b6b2-ced1-4f7a-a098-2c2e369c3ce32
828301cyclobenzaprine hydrochloride 7.5 MG Oral Tablet [Fexmid]SBDa948b6b2-ced1-4f7a-a098-2c2e369c3ce32
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDa948b6b2-ced1-4f7a-a098-2c2e369c3ce32
828301Fexmid 7.5 MG Oral TabletSYa948b6b2-ced1-4f7a-a098-2c2e369c3ce32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0950-15043609500130 in 1 BOTTLEHistorical
50436-0950-25043609500260 in 1 BOTTLEHistorical
50436-0950-35043609500390 in 1 BOTTLEHistorical
50436-0950-450436095004120 in 1 BOTTLEHistorical