FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
50436-9804
11-digit product format
504369804
Labeler code
50436
Product ID
50436-9804_742ad437-e7ae-4c16-b29a-22f9ace672d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077563
Marketing category
ANDA
Marketing start
2006-04-04
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-9804-12024-01-30C16284748780-11030e365-613d-111a-e063-dadaa90a10e2Cyclobenzaprine Hydrochloride Tablets Rx Only
50436-9804-22024-01-30C16284748780-11030e365-613d-111a-e063-dadaa90a10e2Cyclobenzaprine Hydrochloride Tablets Rx Only
50436-9804-32024-01-30C16284748780-11030e365-613d-111a-e063-dadaa90a10e2Cyclobenzaprine Hydrochloride Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-9804-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
50436-9804-2Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
50436-9804-3Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-9804-1EA - Each50436-98041abb7176-9c16-4a93-89c2-0381840cd4ab12022-08-04
50436-9804-2EA - Each50436-98043482ecfc-b317-45c1-8293-0e0b631b37ee12022-08-04
50436-9804-3EA - Each50436-9804943d17b0-feb2-41b5-bc3d-821e6fb2271812022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9804CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 3 package rows20220612_1d76a397-2aec-4614-9b54-059857cfe4d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN1d76a397-2aec-4614-9b54-059857cfe4d82
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD1d76a397-2aec-4614-9b54-059857cfe4d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-9804-15043698040130 TABLET, FILM COATED in 1 BOTTLE (50436-9804-1) 2022-06-010000-00-00NoNoCurrent
50436-9804-25043698040260 TABLET, FILM COATED in 1 BOTTLE (50436-9804-2) 2022-06-010000-00-00NoNoCurrent
50436-9804-35043698040390 TABLET, FILM COATED in 1 BOTTLE (50436-9804-3) 2022-06-010000-00-00NoNoCurrent