FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
50090-3253
11-digit product format
500903253
Labeler code
50090
Product ID
50090-3253_e61f614c-02f9-40e9-a77a-6c68b5e1fd4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090478
Marketing category
ANDA
Marketing start
2016-07-22
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
No
Listing certified through
2022-12-31
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
50090-3253-02023-01-30C16284748780-19d75b9cf-ceb7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HCl TABLETS USP
50090-3253-12023-01-30C16284748780-19d75b9cf-ceb7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HCl TABLETS USP
50090-3253-22023-01-30C16284748780-19d75b9cf-ceb7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HCl TABLETS USP
50090-3253-02021-04-16C16284748780-19d75b9cf-ceb7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HCl TABLETS USP
50090-3253-12021-04-16C16284748780-19d75b9cf-ceb7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HCl TABLETS USP
50090-3253-22021-04-16C16284748780-19d75b9cf-ceb7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HCl TABLETS USP
50090-3253-02020-01-31C16284748780-19d75b9cf-ceb7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HCl TABLETS USP
50090-3253-12020-01-31C16284748780-19d75b9cf-ceb7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HCl TABLETS USP
50090-3253-22020-01-31C16284748780-19d75b9cf-ceb7-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HCl TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3253-0Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED309
50090-3253-1Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED209
50090-3253-2Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3253-0EA - Each50090-3253edd0a2ba-33cc-46b6-9327-542b9721990512019-05-02
50090-3253-1EA - Each50090-32533820ceb6-e2bd-4650-bf1e-7df8369a273612019-05-02
50090-3253-2EA - Each50090-3253fde5fc7d-537b-4783-8227-f3079833821612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3253CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Legacy NDC, 3 package rows20210417_91dae210-b0fb-44d5-93c2-8295c1d19606.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN91dae210-b0fb-44d5-93c2-8295c1d196069
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD91dae210-b0fb-44d5-93c2-8295c1d196069

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3253-05009032530030 TABLET, FILM COATED in 1 BOTTLE (50090-3253-0) 2017-11-090000-00-00NoNoCurrent
50090-3253-15009032530120 TABLET, FILM COATED in 1 BOTTLE (50090-3253-1) 2017-11-130000-00-00NoNoCurrent
50090-3253-25009032530290 TABLET, FILM COATED in 1 BOTTLE (50090-3253-2) 2017-11-130000-00-00NoNoCurrent