Cyclobenzaprine Hydrochloride

Product NDC
50090-5326
11-digit product format
500905326
Labeler code
50090
Product ID
50090-5326_b9cf1305-6415-4f22-99dd-f2528e2503b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077563
Marketing category
ANDA
Marketing start
2017-10-09
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 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
50090-5326-12024-01-30C16284748780-11030e365-0511-111a-e063-dadaa90a10e2Cyclobenzaprine Hydrochloride Tablets Rx Only
50090-5326-22024-01-30C16284748780-11030e365-0511-111a-e063-dadaa90a10e2Cyclobenzaprine Hydrochloride Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5326-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
50090-5326-2Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5326-1EA - Each50090-53263beaddbc-8419-4336-87ce-14d37071e84312022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5326CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20220120_f77a095a-92b6-4809-952e-4feee415a5fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNf77a095a-92b6-4809-952e-4feee415a5fc4
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDf77a095a-92b6-4809-952e-4feee415a5fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5326-15009053260130 TABLET, FILM COATED in 1 BOTTLE (50090-5326-1) 2020-10-300000-00-00NoNoCurrent
50090-5326-25009053260260 TABLET, FILM COATED in 1 BOTTLE (50090-5326-2) 2020-10-300000-00-00NoNoCurrent