Cyclobenzaprine Hydrochloride

Product NDC
50436-0006
11-digit product format
504360006
Labeler code
50436
Product ID
50436-0006_86a7bf58-0772-4e3c-9d23-9923510806df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA078048
Marketing category
ANDA
Marketing start
2014-07-31
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50436-0006-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
50436-0006-3Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905
50436-0006-4Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1205
50436-0006-5Cyclobenzaprine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0006-1EA - Each50436-0006e0fc5eac-794d-4867-b62f-c5e3e8d3470212017-07-07
50436-0006-3EA - Each50436-0006afb695c2-17a3-405a-927d-1d8caa37d67512017-07-07
50436-0006-4EA - Each50436-000656e3d555-91a5-441f-9669-be1793a34cdf12017-07-07
50436-0006-5EA - Each50436-0006b4f21d54-10eb-4970-8103-e794fdaa062412017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0006CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]5Legacy NDC, 4 package rows20210311_baefd44f-9e20-4f7e-b8aa-922a2558e042.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNbaefd44f-9e20-4f7e-b8aa-922a2558e0425
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDbaefd44f-9e20-4f7e-b8aa-922a2558e0425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0006-15043600060130 TABLET, FILM COATED in 1 BOTTLE (50436-0006-1) 2021-03-090000-00-00NoNoCurrent
50436-0006-35043600060390 TABLET, FILM COATED in 1 BOTTLE (50436-0006-3) 2021-03-090000-00-00NoNoCurrent
50436-0006-450436000604120 TABLET, FILM COATED in 1 BOTTLE (50436-0006-4) 2021-03-090000-00-00NoNoCurrent
50436-0006-550436000605180 TABLET, FILM COATED in 1 BOTTLE (50436-0006-5) 2021-03-090000-00-00NoNoCurrent