FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
50268-190
11-digit product format
502680190
Labeler code
50268
Product ID
50268-190_423d93a8-e8b9-b8a0-e063-6294a90a73be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA090478
Marketing category
ANDA
Marketing start
2014-06-10
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-190-11Cyclobenzaprine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED110
50268-190-15Cyclobenzaprine Hydrochloride50 in 1 BOXTABLET, FILM COATED5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-190-11EA - Each50268-190e5388551-0f15-4988-946a-e8f5c311d9ad12015-04-03
50268-190-15EA - Each50268-190a9112343-b225-4078-a695-51a0125976cc12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-190CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]9Current NDC, Legacy NDC, 2 package rows20250112_64f6d1be-4067-a5c7-2343-4aed651a0cac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN64f6d1be-4067-a5c7-2343-4aed651a0cac10
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD64f6d1be-4067-a5c7-2343-4aed651a0cac10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-190-11502680190111 in 1 BLISTER PACKHistorical
50268-190-155026801901550 BLISTER PACK in 1 BOX (50268-190-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-190-11) 50 blister pack2014-06-100000-00-00NoNoCurrent