CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
61919-544
11-digit product format
619190544
Labeler code
61919
Product ID
61919-544_2a7c735b-dfa7-4165-b2ad-d15d5650d6e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090478
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 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
61919-544-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET204
61919-544-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET304
61919-544-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET604
61919-544-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-544-20EA - Each61919-54479de2b8a-6b3b-4c6a-a4e9-dce88e18329112015-11-12
61919-544-30EA - Each61919-5441dee5598-6ec3-427d-816b-23fdba67dfb012015-04-03
61919-544-60EA - Each61919-544dc2f3f27-2bc8-4319-a19c-0f731cfa89ec12015-05-05
61919-544-90EA - Each61919-544cb17a8e7-97da-471a-8329-ea15b57c43f612015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-544CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]4Legacy NDC, 4 package rows20151110_4722979e-a59e-448e-a294-0db91bd7547c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN4722979e-a59e-448e-a294-0db91bd7547c4
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD4722979e-a59e-448e-a294-0db91bd7547c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-544-206191905442020 in 1 BOTTLEHistorical
61919-544-306191905443030 in 1 BOTTLEHistorical
61919-544-606191905446060 in 1 BOTTLEHistorical
61919-544-906191905449090 in 1 BOTTLEHistorical