cyclobenzaprine hydrochloride

Product NDC
53808-1039
11-digit product format
538081039
Labeler code
53808
Product ID
53808-1039_92de62e2-6728-432e-9463-c136b381c204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077563
Marketing category
ANDA
Marketing start
2014-01-01
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
2019-12-31
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
53808-1039-12020-01-31C16284748780-19d75b9d0-bcec-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1039-1cyclobenzaprine hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1039CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141007_879a4e55-012d-4988-b571-9a8cf94414dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN879a4e55-012d-4988-b571-9a8cf94414dd1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD879a4e55-012d-4988-b571-9a8cf94414dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1039-15380810390130 in 1 BLISTER PACKHistorical