Cyclobenzaprine Hydrochloride

Product NDC
50090-2862
11-digit product format
500902862
Labeler code
50090
Product ID
50090-2862_89581385-1046-4a93-afa9-8b5c39ebeb0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071611
Marketing category
ANDA
Marketing start
1989-05-03
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
50090-2862-02020-01-31C16284748780-19d75b9cf-e0c9-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP Revised: August 2016 Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2862-0Cyclobenzaprine Hydrochloride33 in 1 CARTONTABLET, FILM COATED334
50090-2862-0Cyclobenzaprine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2862-0EA - Each50090-28629dc85230-c5b9-4470-84e3-d572fed8026512019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2862CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20190225_cfba6fcb-f58d-4de0-b443-7a6ce3f55448.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNcfba6fcb-f58d-4de0-b443-7a6ce3f554484
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDcfba6fcb-f58d-4de0-b443-7a6ce3f554484

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2862-05009028620033 in 1 CARTONHistorical