Cyclobenzaprine Hydrochloride

Product NDC
71550-101
11-digit product format
715500101
Labeler code
71550
Product ID
71550-101_664ab52d-60d4-a8c8-e053-2a91aa0a7c40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Virtue Rx, LLC
Application
ANDA090478
Marketing category
ANDA
Marketing start
2018-03-01
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
71550-101-012020-01-31C16284748780-19d75b9d0-ee09-f424-e053-dadaa90a57ceCYCLOBENZAPRINE HCl TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71550-101-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71550-101-01EA - Each71550-101b877f165-2fcf-47f5-ad34-1d5922bdbd7a12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71550-101CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [VIRTUE RX, LLC]3Legacy NDC, 1 package rows20180301_c519e446-fa50-487d-a54d-fc3bfdd7d034.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNc519e446-fa50-487d-a54d-fc3bfdd7d0343
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDc519e446-fa50-487d-a54d-fc3bfdd7d0343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71550-101-0171550010101100 in 1 BOTTLEHistorical