FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
45865-962
11-digit product format
458650962
Labeler code
45865
Product ID
45865-962_9aef7721-3553-8eb1-e053-2995a90acfe6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
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
45865-962-202025-01-30C16284748780-12cef2736-6cba-d83d-e063-dadaa90ab31fCyclobenzaprine hydrochloride, USP
45865-962-302025-01-30C16284748780-12cef2736-6cba-d83d-e063-dadaa90ab31fCyclobenzaprine hydrochloride, USP
45865-962-602025-01-30C16284748780-12cef2736-6cba-d83d-e063-dadaa90ab31fCyclobenzaprine hydrochloride, USP
45865-962-902025-01-30C16284748780-12cef2736-6cba-d83d-e063-dadaa90ab31fCyclobenzaprine hydrochloride, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-962-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED201
45865-962-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301
45865-962-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601
45865-962-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-962CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 4 package rows20191231_9aef6535-ab77-8ddf-e053-2995a90a66b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN9aef6535-ab77-8ddf-e053-2995a90a66b91
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD9aef6535-ab77-8ddf-e053-2995a90a66b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-962-204586509622020 TABLET, FILM COATED in 1 BOTTLE (45865-962-20) 2019-12-110000-00-00NoNoCurrent
45865-962-304586509623030 TABLET, FILM COATED in 1 BOTTLE (45865-962-30) 2019-12-110000-00-00NoNoCurrent
45865-962-604586509626060 TABLET, FILM COATED in 1 BOTTLE (45865-962-60) 2019-12-110000-00-00NoNoCurrent
45865-962-904586509629090 TABLET, FILM COATED in 1 BOTTLE (45865-962-90) 2019-12-110000-00-00NoNoCurrent