FDA.reportPublic FDA data

Fexmid

Product NDC
70199-014
11-digit product format
701990014
Labeler code
70199
Product ID
70199-014_7c0ac2af-9747-4d57-8c57-9b0c033c97d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Casper 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
2020-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70199-014-01EA - Each70199-014d29976f7-74e9-4be2-8f2f-eb40019679a112018-07-03

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
70199-014-0170199001401100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70199-014-01) 2018-04-300000-00-00NoNoCurrent