Cyclobenzaprine Hydrochloride

Product NDC
50090-5900
11-digit product format
500905900
Labeler code
50090
Product ID
50090-5900_344b65f1-6603-4c96-b438-154d2b5f389e
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
2021-07-20
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
2023-12-31
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
50090-5900-02024-01-30C16284748780-11030e365-173a-111a-e063-dadaa90a10e2Cyclobenzaprine Hydrochloride Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5900-0Cyclobenzaprine Hydrochloride33 in 1 BOTTLETABLET, FILM COATED331

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5900-0EA - Each50090-590062e4d742-7371-499f-bd67-7c3f74993a4012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5900CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20220122_4e763352-beb4-48d3-a08f-10edf01abc4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4e763352-beb4-48d3-a08f-10edf01abc4a1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4e763352-beb4-48d3-a08f-10edf01abc4a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5900-05009059000033 TABLET, FILM COATED in 1 BOTTLE (50090-5900-0) 2022-01-130000-00-00NoNoCurrent