FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
68788-8167
11-digit product format
687888167
Labeler code
68788
Product ID
68788-8167_6e52b30a-3a9c-47cf-a088-707511645d5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078643
Marketing category
ANDA
Marketing start
2022-04-08
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
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 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
68788-8167-2Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED205
68788-8167-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
68788-8167-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED155
68788-8167-6Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
68788-8167-9Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8167-2EA - Each68788-8167d0d4e965-18b9-4df3-88fc-e8e2ea1ec8bb12022-05-04
68788-8167-3EA - Each68788-8167e38a01f9-95bf-4532-a211-7b5ee142f53f12022-05-04
68788-8167-5EA - Each68788-816754e9c360-484c-410d-aa05-9e58947fdf9612022-05-04
68788-8167-6EA - Each68788-8167b6715798-ef98-454b-b60f-7c269112fee012022-05-04
68788-8167-9EA - Each68788-816794ce0efa-2835-4823-8e14-96f6751ab8cd12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8167CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 5 package rows20250315_014dd648-5b84-4d1d-80fc-a467e2d741ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN014dd648-5b84-4d1d-80fc-a467e2d741ef5
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD014dd648-5b84-4d1d-80fc-a467e2d741ef5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8167-26878881670220 TABLET, FILM COATED in 1 BOTTLE (68788-8167-2) 2022-04-080000-00-00NoNoCurrent
68788-8167-36878881670330 TABLET, FILM COATED in 1 BOTTLE (68788-8167-3) 2022-04-080000-00-00NoNoCurrent
68788-8167-56878881670515 TABLET, FILM COATED in 1 BOTTLE (68788-8167-5) 2022-04-080000-00-00NoNoCurrent
68788-8167-66878881670660 TABLET, FILM COATED in 1 BOTTLE (68788-8167-6) 2022-04-080000-00-00NoNoCurrent
68788-8167-96878881670990 TABLET, FILM COATED in 1 BOTTLE (68788-8167-9) 2022-04-080000-00-00NoNoCurrent