FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
63187-094
11-digit product format
631870094
Labeler code
63187
Product ID
63187-094_6d258146-9e61-40a6-b433-d5fb21aecc5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078048
Marketing category
ANDA
Marketing start
2014-07-31
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
63187-094-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED108
63187-094-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED158
63187-094-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED308
63187-094-40Cyclobenzaprine Hydrochloride40 in 1 BOTTLETABLET, FILM COATED408
63187-094-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED608
63187-094-72Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1208
63187-094-78Cyclobenzaprine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1808
63187-094-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-094-10EA - Each63187-0945eae3dba-cff9-47f1-aa6d-3952cd35d35f12019-04-11
63187-094-15EA - Each63187-094c57d730f-7f5e-436d-8a5f-72d1e110ee4012020-02-13
63187-094-30EA - Each63187-0945698c98d-2aa3-43ee-8c7f-13e0d365352d12023-08-08
63187-094-40EA - Each63187-0941f4eb243-2940-447e-a09d-4179f3edbcbf12020-05-08
63187-094-60EA - Each63187-094ab6bb967-c7f5-4f17-9293-9b8fa69d2f1f12023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-094CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]8Current NDC, Legacy NDC, 8 package rows20211020_f14bc532-e30f-490f-b97b-d0dab9a2ba0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf14bc532-e30f-490f-b97b-d0dab9a2ba0c8
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf14bc532-e30f-490f-b97b-d0dab9a2ba0c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-094-106318700941010 TABLET, FILM COATED in 1 BOTTLE (63187-094-10) 2018-06-010000-00-00NoNoCurrent
63187-094-156318700941515 TABLET, FILM COATED in 1 BOTTLE (63187-094-15) 2020-01-130000-00-00NoNoCurrent
63187-094-306318700943030 TABLET, FILM COATED in 1 BOTTLE (63187-094-30) 2015-07-010000-00-00NoNoCurrent
63187-094-406318700944040 TABLET, FILM COATED in 1 BOTTLE (63187-094-40) 2020-03-240000-00-00NoNoCurrent
63187-094-606318700946060 TABLET, FILM COATED in 1 BOTTLE (63187-094-60) 2015-07-010000-00-00NoNoCurrent
63187-094-7263187009472120 TABLET, FILM COATED in 1 BOTTLE (63187-094-72) 2015-07-010000-00-00NoNoCurrent
63187-094-7863187009478180 TABLET, FILM COATED in 1 BOTTLE (63187-094-78) 2015-07-010000-00-00NoNoCurrent
63187-094-906318700949090 TABLET, FILM COATED in 1 BOTTLE (63187-094-90) 2015-07-010000-00-00NoNoCurrent