FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
50436-0846
11-digit product format
504360846
Labeler code
50436
Product ID
50436-0846_3ba3933c-d2e8-4ab6-8490-4c933c8ba232
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA090478
Marketing category
ANDA
Marketing start
2016-07-22
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
2020-12-31
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
50436-0846-12021-01-29C16284748780-1ba0f9c33-370e-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCl TABLETS USP
50436-0846-22021-01-29C16284748780-1ba0f9c33-370e-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCl TABLETS USP
50436-0846-32021-01-29C16284748780-1ba0f9c33-370e-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCl TABLETS USP
50436-0846-42021-01-29C16284748780-1ba0f9c33-370e-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCl TABLETS USP
50436-0846-52021-01-29C16284748780-1ba0f9c33-370e-a910-e053-dadaa90a0b85CYCLOBENZAPRINE HCl TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0846-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
50436-0846-2Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
50436-0846-3Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904
50436-0846-4Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED204
50436-0846-5Cyclobenzaprine Hydrochloride12 in 1 BOTTLETABLET, FILM COATED124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0846-1EA - Each50436-0846f4f559f7-0500-4ae0-bdde-d1e1efd4237b12017-09-11
50436-0846-2EA - Each50436-08463f134d93-60b3-43e4-b0d1-ada9abb8edf812017-09-11
50436-0846-3EA - Each50436-08466f79ac1a-dea6-48f8-b592-fc55020712d512017-09-11
50436-0846-4EA - Each50436-0846f1ea5e52-6b09-4054-a9d5-da20783565bf12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0846CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [UNIT DOSE SERVICES]4Legacy NDC, 5 package rows20170822_f4432fc3-ec30-46c6-84aa-19dcf59dfe91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf4432fc3-ec30-46c6-84aa-19dcf59dfe914
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf4432fc3-ec30-46c6-84aa-19dcf59dfe914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0846-15043608460130 in 1 BOTTLEHistorical
50436-0846-25043608460260 in 1 BOTTLEHistorical
50436-0846-35043608460390 in 1 BOTTLEHistorical
50436-0846-45043608460420 in 1 BOTTLEHistorical
50436-0846-55043608460512 in 1 BOTTLEHistorical