FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
68387-500
11-digit product format
683870500
Labeler code
68387
Product ID
68387-500_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
2006-08-24
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
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
68387-500-102019-10-21C16284748780-1956f9ecf-c67b-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets USP Rx only
68387-500-152019-10-21C16284748780-1956f9ecf-c67b-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets USP Rx only
68387-500-302019-10-21C16284748780-1956f9ecf-c67b-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets USP Rx only
68387-500-452019-10-21C16284748780-1956f9ecf-c67b-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets USP Rx only
68387-500-602019-10-21C16284748780-1956f9ecf-c67b-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets USP Rx only
68387-500-902019-10-21C16284748780-1956f9ecf-c67b-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-500-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET102
68387-500-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET152
68387-500-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
68387-500-45Cyclobenzaprine Hydrochloride45 in 1 BOTTLE, PLASTICTABLET452
68387-500-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
68387-500-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-500-10EA - Each68387-500b318b38d-b1b9-41c0-abcd-7e4248f934e212012-07-24
68387-500-15EA - Each68387-500866b80a5-7384-4a93-ae97-9cb01fa5b91812012-07-24
68387-500-30EA - Each68387-5004dfead62-f6ed-4666-8f29-a373f96cc68b12012-07-24
68387-500-45EA - Each68387-5007bd2134a-da64-4a49-bd9f-85fdd6b503ce12012-07-24
68387-500-60EA - Each68387-500c5829af6-42f5-4044-9b84-7a31d71d5ed312012-07-24
68387-500-90EA - Each68387-500272f4e64-b841-4297-89fc-80d66c8762f712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-500CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2Legacy NDC, 6 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
68387-500-106838705001010 in 1 BOTTLE, PLASTICHistorical
68387-500-156838705001515 in 1 BOTTLE, PLASTICHistorical
68387-500-306838705003030 in 1 BOTTLE, PLASTICHistorical
68387-500-456838705004545 in 1 BOTTLE, PLASTICHistorical
68387-500-606838705006060 in 1 BOTTLE, PLASTICHistorical
68387-500-906838705009090 in 1 BOTTLE, PLASTICHistorical