Cyclobenzaprine Hydrochloride

Product NDC
12634-528
11-digit product format
126340528
Labeler code
12634
Product ID
12634-528_27fe4bb9-282f-42ca-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA090478
Marketing category
ANDA
Marketing start
2012-04-02
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
2019-12-31
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
12634-528-002020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-012020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-522020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-542020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-572020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-592020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-602020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-612020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-632020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-662020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-672020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-692020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-712020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-742020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-782020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-802020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-812020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-822020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-852020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-912020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-942020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-952020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
12634-528-962020-01-31C16284748780-19d75b9cf-fca1-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-528-00Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET105
12634-528-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET1005
12634-528-52Cyclobenzaprine Hydrochloride12 in 1 BLISTER PACKTABLET125
12634-528-54Cyclobenzaprine Hydrochloride14 in 1 BLISTER PACKTABLET145
12634-528-57Cyclobenzaprine Hydrochloride20 in 1 BLISTER PACKTABLET205
12634-528-59Cyclobenzaprine Hydrochloride30 in 1 BLISTER PACKTABLET305
12634-528-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET605
12634-528-61Cyclobenzaprine Hydrochloride10 in 1 BLISTER PACKTABLET105
12634-528-63Cyclobenzaprine Hydrochloride3 in 1 BLISTER PACKTABLET35
12634-528-66Cyclobenzaprine Hydrochloride6 in 1 BLISTER PACKTABLET65
12634-528-67Cyclobenzaprine Hydrochloride7 in 1 BLISTER PACKTABLET75
12634-528-69Cyclobenzaprine Hydrochloride9 in 1 BLISTER PACKTABLET95
12634-528-71Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET305
12634-528-74Cyclobenzaprine Hydrochloride24 in 1 BOTTLETABLET245
12634-528-78Cyclobenzaprine Hydrochloride28 in 1 BOTTLETABLET285
12634-528-80Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET205
12634-528-81Cyclobenzaprine Hydrochloride21 in 1 BOTTLETABLET215
12634-528-82Cyclobenzaprine Hydrochloride12 in 1 BOTTLETABLET125
12634-528-85Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET155
12634-528-91Cyclobenzaprine Hydrochloride1 in 1 BLISTER PACKTABLET15
12634-528-94Cyclobenzaprine Hydrochloride4 in 1 BOTTLETABLET45
12634-528-95Cyclobenzaprine Hydrochloride5 in 1 BOTTLETABLET55
12634-528-96Cyclobenzaprine Hydrochloride6 in 1 BOTTLETABLET65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-528-00EA - Each12634-52815fb067a-e3c3-4fea-9d84-c5c590a491d012016-01-13
12634-528-60EA - Each12634-528b0d870f2-93db-41a7-a9e5-7f2775b4a8b512016-01-13
12634-528-71EA - Each12634-528ed4fe9fc-4ec2-49dd-88b6-877a754a75dc12016-01-13
12634-528-81EA - Each12634-5284ab8220b-5b0e-446a-9c7e-f476e32a9a9212016-01-13
12634-528-85EA - Each12634-528645c3ebe-d4b7-4bed-b03d-61b0bf0b29b312016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-528CYCLOBENZAPRINE HYDROCHLORIDE TABLET [APOTHECA INC.]5Legacy NDC, 23 package rows20151229_27327397-3ff7-6e43-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN27327397-3ff7-6e43-e054-00144ff88e885
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD27327397-3ff7-6e43-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-528-001263405280010 in 1 BOTTLEHistorical
12634-528-0112634052801100 in 1 BOTTLEHistorical
12634-528-521263405285212 in 1 BLISTER PACKHistorical
12634-528-541263405285414 in 1 BLISTER PACKHistorical
12634-528-571263405285720 in 1 BLISTER PACKHistorical
12634-528-591263405285930 in 1 BLISTER PACKHistorical
12634-528-601263405286060 in 1 BOTTLEHistorical
12634-528-611263405286110 in 1 BLISTER PACKHistorical
12634-528-63126340528633 in 1 BLISTER PACKHistorical
12634-528-66126340528666 in 1 BLISTER PACKHistorical
12634-528-67126340528677 in 1 BLISTER PACKHistorical
12634-528-69126340528699 in 1 BLISTER PACKHistorical
12634-528-711263405287130 in 1 BOTTLEHistorical
12634-528-741263405287424 in 1 BOTTLEHistorical
12634-528-781263405287828 in 1 BOTTLEHistorical
12634-528-801263405288020 in 1 BOTTLEHistorical
12634-528-811263405288121 in 1 BOTTLEHistorical
12634-528-821263405288212 in 1 BOTTLEHistorical
12634-528-851263405288515 in 1 BOTTLEHistorical
12634-528-91126340528911 in 1 BLISTER PACKHistorical
12634-528-94126340528944 in 1 BOTTLEHistorical
12634-528-95126340528955 in 1 BOTTLEHistorical
12634-528-96126340528966 in 1 BOTTLEHistorical