Cyclobenzaprine Hydrochloride

Product NDC
63187-342
11-digit product format
631870342
Labeler code
63187
Product ID
63187-342_27151a8c-fa4a-40ea-aa84-99a220bdc51f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090478
Marketing category
ANDA
Marketing start
2012-04-02
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-342-15EA - Each63187-342a9af3660-c4b6-4933-9381-a732ddf7385812015-05-05
63187-342-21EA - Each63187-3428f315c7e-03af-4c79-a0ca-f05fc6b228d112016-04-04
63187-342-30EA - Each63187-3425baa9c54-2d32-4e88-93e1-e15651585d8012015-12-02
63187-342-45EA - Each63187-342d7ab5b09-55ad-42a1-866d-44745e7a74cf12016-09-02
63187-342-60EA - Each63187-3429f0cb352-11fb-42ad-8c4f-e7e9ec4bb18212015-08-04
63187-342-90EA - Each63187-342b2764be1-2874-4c79-ba2d-d40a265852a212015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-342CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]9Legacy NDC20210116_aa465412-089e-42a3-afa6-4a2aac5a8b23.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-342-106318703421010 TABLET in 1 BOTTLE (63187-342-10) 10 tablet2014-04-010000-00-00NoNoCurrent
63187-342-156318703421524 BOTTLE in 1 CASE (63187-342-15) > 15 TABLET in 1 BOTTLE24 bottle2014-04-010000-00-00NoNoCurrent
63187-342-206318703422020 TABLET in 1 BOTTLE (63187-342-20) 20 tablet2014-04-010000-00-00NoNoCurrent
63187-342-216318703422121 TABLET in 1 BOTTLE (63187-342-21) 21 tablet2014-04-010000-00-00NoNoCurrent
63187-342-306318703423024 BOTTLE in 1 CASE (63187-342-30) > 30 TABLET in 1 BOTTLE24 bottle2014-04-010000-00-00NoNoCurrent
63187-342-456318703424524 BOTTLE in 1 CASE (63187-342-45) > 45 TABLET in 1 BOTTLE24 bottle2014-04-010000-00-00NoNoCurrent
63187-342-606318703426024 BOTTLE in 1 CASE (63187-342-60) > 60 TABLET in 1 BOTTLE24 bottle2014-04-010000-00-00NoNoCurrent
63187-342-906318703429090 TABLET in 1 BOTTLE (63187-342-90) 90 tablet2014-04-010000-00-00NoNoCurrent