FDA.reportPublic FDA data

CYCLOBENZAPRINE HYROCHLORIDE

Product NDC
42254-239
11-digit product format
422540239
Labeler code
42254
Product ID
42254-239_92f5c528-e1af-4268-9f5f-ae5558a5104c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078722
Marketing category
ANDA
Marketing start
2011-08-29
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-239-302019-09-24C16284748780-19350213a-3d2b-c013-e053-90daa90a1393CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
42254-239-602019-09-24C16284748780-19350213a-3d2b-c013-e053-90daa90a1393CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-239-30CYCLOBENZAPRINE HYROCHLORIDE30 in 1 BOTTLETABLET301
42254-239-60CYCLOBENZAPRINE HYROCHLORIDE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-239-30EA - Each42254-23940ab231a-c1d0-4a52-a80d-cc825e7d1b4f12013-02-13
42254-239-60EA - Each42254-2394fcfca5d-f0be-4a6f-9a1e-1f27e9f7ac5412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-239CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20121201_92f5c528-e1af-4268-9f5f-ae5558a5104c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN92f5c528-e1af-4268-9f5f-ae5558a5104c1
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD92f5c528-e1af-4268-9f5f-ae5558a5104c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-239-304225402393030 in 1 BOTTLEHistorical
42254-239-604225402396060 in 1 BOTTLEHistorical