Fexmid

Product NDC
21695-830
11-digit product format
216950830
Labeler code
21695
Product ID
21695-830_99aca2c3-afe6-4f74-83b8-beb08bb2b502
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA071611
Marketing category
ANDA
Marketing start
2008-11-01
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
E
Listing certified through
2017-12-31
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
21695-830-30Fexmid30 in 1 BOTTLETABLET, FILM COATED301
21695-830-60Fexmid60 in 1 BOTTLETABLET, FILM COATED601
21695-830-72Fexmid120 in 1 BOTTLETABLET, FILM COATED1201
21695-830-90Fexmid90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-830-30EA - Each21695-8300f7982f8-865b-4d17-97dd-bfb74a08e75612012-07-24
21695-830-60EA - Each21695-830ed129e06-a429-4783-a45f-45e9c92bafa112012-07-24
21695-830-72EA - Each21695-8303be09e2d-5ee1-4716-bf29-764a1d5dd83612012-07-24
21695-830-90EA - Each21695-830e96db4e7-156b-442c-95df-33be9bf47d9112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cyclobenzaprine hydrochlorideACTIVE INGREDIENT0VE05JYS2PFEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
cyclobenzaprineACTIVE MOIETY69O5WQQ5TIFEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
anhydrous DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JFEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48FEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4FEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-830FEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20110414_99aca2c3-afe6-4f74-83b8-beb08bb2b502.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN99aca2c3-afe6-4f74-83b8-beb08bb2b5021
828301Fexmid 7.5 MG Oral TabletPSN99aca2c3-afe6-4f74-83b8-beb08bb2b5021
828301cyclobenzaprine hydrochloride 7.5 MG Oral Tablet [Fexmid]SBD99aca2c3-afe6-4f74-83b8-beb08bb2b5021
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD99aca2c3-afe6-4f74-83b8-beb08bb2b5021
828301Fexmid 7.5 MG Oral TabletSY99aca2c3-afe6-4f74-83b8-beb08bb2b5021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-830-302169508303030 in 1 BOTTLEHistorical
21695-830-602169508306060 in 1 BOTTLEHistorical
21695-830-7221695083072120 in 1 BOTTLEHistorical
21695-830-902169508309090 in 1 BOTTLEHistorical