FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
72189-080
11-digit product format
721890080
Labeler code
72189
Product ID
72189-080_2be81315-9d30-1301-e063-6394a90a6a84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA208170
Marketing category
ANDA
Marketing start
2020-05-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828348

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
72189-080-07CYCLOBENZAPRINE HYDROCHLORIDE7 in 1 BOTTLETABLET, FILM COATED78
72189-080-10CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED108
72189-080-15CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED158
72189-080-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED208
72189-080-21CYCLOBENZAPRINE HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED218
72189-080-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
72189-080-45CYCLOBENZAPRINE HYDROCHLORIDE45 in 1 BOTTLETABLET, FILM COATED458
72189-080-60CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED608
72189-080-72CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1208
72189-080-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-080-07EA - Each72189-08099cbf031-938c-4d63-a8a5-dad0a5e8f11712021-06-02
72189-080-10EA - Each72189-0805447b4f7-84da-4215-af68-4cf46bcdfc1012021-01-08
72189-080-15EA - Each72189-080f393c4c7-ad10-4a1d-8371-6fb641b6c10412021-01-08
72189-080-20EA - Each72189-08022035822-31db-43e1-8c73-71bf0957ebfa12021-12-08
72189-080-30EA - Each72189-08031ea2f4e-1a8b-42e1-bdec-cc79ea7f400b12020-06-05
72189-080-60EA - Each72189-080c0d7e484-0784-41da-b2a9-d9fee57dbce712020-06-05
72189-080-72EA - Each72189-08062ce3ada-7b57-43b8-bd96-915cec9cd22112020-06-05
72189-080-90EA - Each72189-080f123adf7-8b13-4f05-a8ce-f712865388a212020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-080CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]8Current NDC, Legacy NDC, 10 package rows20250119_a58cf759-048b-6740-e053-2a95a90a8b43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNa58cf759-048b-6740-e053-2a95a90a8b438
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDa58cf759-048b-6740-e053-2a95a90a8b438

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-080-07721890080077 TABLET, FILM COATED in 1 BOTTLE (72189-080-07) 2020-05-130000-00-00NoNoCurrent
72189-080-107218900801010 TABLET, FILM COATED in 1 BOTTLE (72189-080-10) 2020-05-130000-00-00NoNoCurrent
72189-080-157218900801515 TABLET, FILM COATED in 1 BOTTLE (72189-080-15) 2020-05-130000-00-00NoNoCurrent
72189-080-207218900802020 TABLET, FILM COATED in 1 BOTTLE (72189-080-20) 2020-05-130000-00-00NoNoCurrent
72189-080-217218900802121 TABLET, FILM COATED in 1 BOTTLE (72189-080-21) 2020-05-130000-00-00NoNoCurrent
72189-080-307218900803030 TABLET, FILM COATED in 1 BOTTLE (72189-080-30) 2020-05-130000-00-00NoNoCurrent
72189-080-457218900804545 TABLET, FILM COATED in 1 BOTTLE (72189-080-45) 2020-05-130000-00-00NoNoCurrent
72189-080-607218900806060 TABLET, FILM COATED in 1 BOTTLE (72189-080-60) 2020-05-130000-00-00NoNoCurrent
72189-080-7272189008072120 TABLET, FILM COATED in 1 BOTTLE (72189-080-72) 2020-05-130000-00-00NoNoCurrent
72189-080-907218900809090 TABLET, FILM COATED in 1 BOTTLE (72189-080-90) 2020-05-130000-00-00NoNoCurrent