FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
72888-012
11-digit product format
728880012
Labeler code
72888
Product ID
72888-012_484568be-57f8-943e-e063-6394a90a589b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299, 828320, 828348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-012-00CYCLOBENZAPRINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10006
72888-012-01CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1006
72888-012-05CYCLOBENZAPRINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-012-00EA - Each72888-012f94839aa-cc0a-4b29-912a-ed4750bda93c12022-05-04
72888-012-01EA - Each72888-012fdd2b8e6-4b55-4040-9951-8e478500c7f712021-04-08
72888-012-05EA - Each72888-0124616a1aa-b04d-4335-9344-66226c9372eb12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-012CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ADVAGEN PHARMA LIMITED]5Current NDC, Legacy NDC, 3 package rows20241222_b2169957-9083-412c-a175-3071860c2b43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN5d536e88-62be-45bd-bd09-0efc53fe12b911
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD5d536e88-62be-45bd-bd09-0efc53fe12b911
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb2169957-9083-412c-a175-3071860c2b436
828320cyclobenzaprine HCl 5 MG Oral TabletPSNb2169957-9083-412c-a175-3071860c2b436
828320cyclobenzaprine HCl 5 MG Oral TabletPSN4eaa675a-c24c-4043-8fdf-9d59e5e4f4d56
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNb2169957-9083-412c-a175-3071860c2b436
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDb2169957-9083-412c-a175-3071860c2b436
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDb2169957-9083-412c-a175-3071860c2b436
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD4eaa675a-c24c-4043-8fdf-9d59e5e4f4d56
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDb2169957-9083-412c-a175-3071860c2b436
828320cyclobenzaprine HCl 5 MG Oral TabletPSN01e18825-1cf9-a98c-e063-6294a90ae0a45
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD01e18825-1cf9-a98c-e063-6294a90ae0a45
828320cyclobenzaprine HCl 5 MG Oral TabletPSN00b20a8c-debd-e930-e063-6394a90a7ed04
828320cyclobenzaprine HCl 5 MG Oral TabletPSNe4e8bab3-c5e7-4d2b-9692-ee6c6799b1204
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD00b20a8c-debd-e930-e063-6394a90a7ed04
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDe4e8bab3-c5e7-4d2b-9692-ee6c6799b1204
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf708cf0f-8373-14a2-e053-6394a90ab3fe3
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf708cf0f-8373-14a2-e053-6394a90ab3fe3
828348cyclobenzaprine HCl 10 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828320cyclobenzaprine HCl 5 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828320cyclobenzaprine HCl 5 MG Oral TabletPSN05641925-7b10-4b30-b6e8-44b416a5e77e2
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD05641925-7b10-4b30-b6e8-44b416a5e77e2
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD418e3974-f7dd-4f27-bee5-3c2fb0531c4c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-012-00728880012001000 TABLET, FILM COATED in 1 BOTTLE (72888-012-00) 2021-11-010000-00-00NoNoCurrent
72888-012-0172888001201100 TABLET, FILM COATED in 1 BOTTLE (72888-012-01) 2017-05-310000-00-00NoNoCurrent
72888-012-0572888001205500 TABLET, FILM COATED in 1 BOTTLE (72888-012-05) 2017-05-310000-00-00NoNoCurrent