Cyclobenzaprine Hydrochloride

Product NDC
68387-502
11-digit product format
683870502
Labeler code
68387
Product ID
68387-502_a29e48fd-183b-49af-ba71-7eec24bcd115
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA071611
Marketing category
ANDA
Marketing start
2010-06-10
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
68387-502-902019-10-21C16284748780-1956f9ecf-c67b-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-502-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-502-90EA - Each68387-502147c4ed5-8b5f-4df3-93c4-0d9d6137201b12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-502CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2Legacy NDC, 1 package rows20100908_220ebc47-d310-4668-8b51-47a4981b46ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN220ebc47-d310-4668-8b51-47a4981b46ef2
828320cyclobenzaprine HCl 5 MG Oral TabletPSN220ebc47-d310-4668-8b51-47a4981b46ef2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD220ebc47-d310-4668-8b51-47a4981b46ef2
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD220ebc47-d310-4668-8b51-47a4981b46ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-502-906838705029090 in 1 BOTTLE, PLASTICHistorical