FDA.reportPublic FDA data

Fexmid

Product NDC
53149-4850
11-digit product format
531494850
Labeler code
53149
Product ID
53149-4850_84b2a2f5-7806-488a-ae52-5616932254fd
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
2018-04-30
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
2021-12-31
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
53149-4850-12022-01-28C16284748780-1d6a99b39-ecee-a426-e053-dadaa90af4c2Fexmid ® 7.5 mg cyclobenzaprine HCl Tablets USP Rx only
53149-4850-32022-01-28C16284748780-1d6a99b39-ecee-a426-e053-dadaa90af4c2Fexmid ® 7.5 mg cyclobenzaprine HCl Tablets USP Rx only
53149-4850-62022-01-28C16284748780-1d6a99b39-ecee-a426-e053-dadaa90af4c2Fexmid ® 7.5 mg cyclobenzaprine HCl Tablets USP Rx only
53149-4850-92022-01-28C16284748780-1d6a99b39-ecee-a426-e053-dadaa90af4c2Fexmid ® 7.5 mg cyclobenzaprine HCl Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-4850-1Fexmid120 in 1 BOTTLETABLET, FILM COATED1204
53149-4850-3Fexmid30 in 1 BOTTLETABLET, FILM COATED304
53149-4850-6Fexmid60 in 1 BOTTLETABLET, FILM COATED604
53149-4850-9Fexmid90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53149-4850-1EA - Each53149-4850a3a21a25-d403-4ad3-984a-4feb43f03f1212019-02-13
53149-4850-3EA - Each53149-485087d82897-ddbf-4883-991e-3656b78ce00a12019-02-13
53149-4850-6EA - Each53149-485084edcdb1-639c-40b4-8450-ff11a0d6e64b12019-02-13
53149-4850-9EA - Each53149-4850c6bd755c-da91-47d7-963a-bc210803996f12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-4850FEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [ALL PHARMA, LLC]4Legacy NDC, 4 package rows20200117_d6057052-1b8f-4e6d-a386-026751d81da5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNd6057052-1b8f-4e6d-a386-026751d81da54
828301Fexmid 7.5 MG Oral TabletPSNd6057052-1b8f-4e6d-a386-026751d81da54
828301cyclobenzaprine hydrochloride 7.5 MG Oral Tablet [Fexmid]SBDd6057052-1b8f-4e6d-a386-026751d81da54
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDd6057052-1b8f-4e6d-a386-026751d81da54
828301Fexmid 7.5 MG Oral TabletSYd6057052-1b8f-4e6d-a386-026751d81da54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53149-4850-153149485001120 TABLET, FILM COATED in 1 BOTTLE (53149-4850-1) 2018-08-130000-00-00NoNoCurrent
53149-4850-35314948500330 TABLET, FILM COATED in 1 BOTTLE (53149-4850-3) 2018-08-130000-00-00NoNoCurrent
53149-4850-65314948500660 TABLET, FILM COATED in 1 BOTTLE (53149-4850-6) 2018-08-130000-00-00NoNoCurrent
53149-4850-95314948500990 TABLET, FILM COATED in 1 BOTTLE (53149-4850-9) 2018-08-130000-00-00NoNoCurrent