FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
53217-170
11-digit product format
532170170
Labeler code
53217
Product ID
53217-170_f134ef66-ee3d-4d29-a5d5-849abeadc033
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 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
53217-170-152020-01-31C16284748780-19d75b9d0-ac24-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
53217-170-302020-01-31C16284748780-19d75b9d0-ac24-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
53217-170-602020-01-31C16284748780-19d75b9d0-ac24-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
53217-170-902020-01-31C16284748780-19d75b9d0-ac24-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-170-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED151
53217-170-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
53217-170-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
53217-170-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-170-15EA - Each53217-1705d8ac728-074b-4a5f-bc8d-843b8a38889412016-01-13
53217-170-30EA - Each53217-17030b91631-a1a3-4d4a-a519-7c5a3e411b0b12016-01-13
53217-170-60EA - Each53217-170ba33fe90-7ad0-40d2-956e-b05a9dd34faf12016-01-13
53217-170-90EA - Each53217-17014f12ee9-a5e1-40a1-bb48-f4e31dd4c9cf12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-170CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20151211_7d34c867-7857-480f-b91d-674b49b248b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN7d34c867-7857-480f-b91d-674b49b248b31
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD7d34c867-7857-480f-b91d-674b49b248b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-170-155321701701515 in 1 BOTTLE, PLASTICHistorical
53217-170-305321701703030 in 1 BOTTLE, PLASTICHistorical
53217-170-605321701706060 in 1 BOTTLE, PLASTICHistorical
53217-170-905321701709090 in 1 BOTTLE, PLASTICHistorical