FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
72888-013
11-digit product format
728880013
Labeler code
72888
Product ID
72888-013_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
7.5 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 HYDROCHLORIDE7.5 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
72888-013-01CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-013-01EA - Each72888-0135f9b2fad-2c55-4032-964f-d5232b29f8b312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-013CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ADVAGEN PHARMA LIMITED]5Current NDC, Legacy NDC, 1 package rows20241222_b2169957-9083-412c-a175-3071860c2b43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb2169957-9083-412c-a175-3071860c2b436
828320cyclobenzaprine HCl 5 MG Oral TabletPSNb2169957-9083-412c-a175-3071860c2b436
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
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDb2169957-9083-412c-a175-3071860c2b436
828348cyclobenzaprine HCl 10 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828320cyclobenzaprine HCl 5 MG Oral TabletPSN418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
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
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD418e3974-f7dd-4f27-bee5-3c2fb0531c4c2
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNedb1e8e3-6388-7976-e053-2a95a90a11cd1
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDedb1e8e3-6388-7976-e053-2a95a90a11cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-013-0172888001301100 TABLET, FILM COATED in 1 BOTTLE (72888-013-01) 2017-05-310000-00-00NoNoCurrent