Cyclobenzaprine Hydrochloride

Product NDC
53808-0639
11-digit product format
538080639
Labeler code
53808
Product ID
53808-0639_fe96ad53-5780-4544-89c5-05f18b25b4c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA078643
Marketing category
ANDA
Marketing start
2013-01-01
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
53808-0639-12020-01-31C16284748780-19d75b9d0-d2f1-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0639-1Cyclobenzaprine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0639CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140404_c62f6022-aafd-456e-b52c-99cd1cc5c3c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNc62f6022-aafd-456e-b52c-99cd1cc5c3c61
828320cyclobenzaprine HCl 5 MG Oral TabletPSNc62f6022-aafd-456e-b52c-99cd1cc5c3c61
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDc62f6022-aafd-456e-b52c-99cd1cc5c3c61
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDc62f6022-aafd-456e-b52c-99cd1cc5c3c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0639-15380806390130 in 1 BLISTER PACKHistorical