FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
67046-148
11-digit product format
670460148
Labeler code
67046
Product ID
67046-148_7d65edf1-3f0e-4ed6-e053-2a91aa0ab996
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler Enterprises
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
67046-148-072022-01-28C16284748780-1d6a99b39-4fb5-a426-e053-dadaa90af4c2148 Cyclobenzaprine 10 mg CYCLOBENZAPRINE HCl TABLETS USP
67046-148-142022-01-28C16284748780-1d6a99b39-4fb5-a426-e053-dadaa90af4c2148 Cyclobenzaprine 10 mg CYCLOBENZAPRINE HCl TABLETS USP
67046-148-152022-01-28C16284748780-1d6a99b39-4fb5-a426-e053-dadaa90af4c2148 Cyclobenzaprine 10 mg CYCLOBENZAPRINE HCl TABLETS USP
67046-148-202022-01-28C16284748780-1d6a99b39-4fb5-a426-e053-dadaa90af4c2148 Cyclobenzaprine 10 mg CYCLOBENZAPRINE HCl TABLETS USP
67046-148-212022-01-28C16284748780-1d6a99b39-4fb5-a426-e053-dadaa90af4c2148 Cyclobenzaprine 10 mg CYCLOBENZAPRINE HCl TABLETS USP
67046-148-282022-01-28C16284748780-1d6a99b39-4fb5-a426-e053-dadaa90af4c2148 Cyclobenzaprine 10 mg CYCLOBENZAPRINE HCl TABLETS USP
67046-148-302022-01-28C16284748780-1d6a99b39-4fb5-a426-e053-dadaa90af4c2148 Cyclobenzaprine 10 mg CYCLOBENZAPRINE HCl TABLETS USP
67046-148-602022-01-28C16284748780-1d6a99b39-4fb5-a426-e053-dadaa90af4c2148 Cyclobenzaprine 10 mg CYCLOBENZAPRINE HCl TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-148-07Cyclobenzaprine Hydrochloride7 in 1 BLISTER PACKTABLET, FILM COATED73
67046-148-14Cyclobenzaprine Hydrochloride14 in 1 BLISTER PACKTABLET, FILM COATED143
67046-148-15Cyclobenzaprine Hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED153
67046-148-20Cyclobenzaprine Hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED203
67046-148-21Cyclobenzaprine Hydrochloride21 in 1 BLISTER PACKTABLET, FILM COATED213
67046-148-28Cyclobenzaprine Hydrochloride28 in 1 BLISTER PACKTABLET, FILM COATED283
67046-148-30Cyclobenzaprine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED303
67046-148-60Cyclobenzaprine Hydrochloride60 in 1 BLISTER PACKTABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-148CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [COUPLER ENTERPRISES]3Legacy NDC, 8 package rows20181220_4deda6bd-60ff-1690-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4deda6bd-60ff-1690-e054-00144ff8d46c3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4deda6bd-60ff-1690-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-148-07670460148077 TABLET, FILM COATED in 1 BLISTER PACK (67046-148-07) 2017-10-050000-00-00NoNoCurrent
67046-148-146704601481414 TABLET, FILM COATED in 1 BLISTER PACK (67046-148-14) 2017-10-050000-00-00NoNoCurrent
67046-148-156704601481515 TABLET, FILM COATED in 1 BLISTER PACK (67046-148-15) 2017-10-050000-00-00NoNoCurrent
67046-148-206704601482020 TABLET, FILM COATED in 1 BLISTER PACK (67046-148-20) 2017-10-050000-00-00NoNoCurrent
67046-148-216704601482121 TABLET, FILM COATED in 1 BLISTER PACK (67046-148-21) 2017-10-050000-00-00NoNoCurrent
67046-148-286704601482828 TABLET, FILM COATED in 1 BLISTER PACK (67046-148-28) 2017-10-050000-00-00NoNoCurrent
67046-148-306704601483030 TABLET, FILM COATED in 1 BLISTER PACK (67046-148-30) 2017-08-010000-00-00NoNoCurrent
67046-148-606704601486060 TABLET, FILM COATED in 1 BLISTER PACK (67046-148-60) 2017-08-010000-00-00NoNoCurrent