Cyclobenzaprine Hydrochloride

Product NDC
50090-4420
11-digit product format
500904420
Labeler code
50090
Product ID
50090-4420_81061b3b-100a-4c37-9f03-2f1b3da6a229
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077797
Marketing category
ANDA
Marketing start
2017-03-30
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
2021-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4420-0Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151
50090-4420-1Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4420CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20200711_2f976e5f-b9c1-48e1-94f4-e85a8fd03fb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN2f976e5f-b9c1-48e1-94f4-e85a8fd03fb91
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD2f976e5f-b9c1-48e1-94f4-e85a8fd03fb91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4420-05009044200015 TABLET, FILM COATED in 1 BOTTLE (50090-4420-0) 2019-07-170000-00-00NoNoCurrent
50090-4420-15009044200115 TABLET, FILM COATED in 1 BOTTLE (50090-4420-1) 2019-07-170000-00-00NoNoCurrent