FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
68788-8221
11-digit product format
687888221
Labeler code
68788
Product ID
68788-8221_b81515f8-f4d3-4e71-82d0-830652940588
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
2022-09-09
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
Rxcui828320

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
68788-8221-2Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED205
68788-8221-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
68788-8221-6Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
68788-8221-8Cyclobenzaprine Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1205
68788-8221-9Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8221-2EA - Each68788-822124f2cc51-5f21-46ac-87b8-1903e1743b4e12022-09-12
68788-8221-3EA - Each68788-8221a8f358dc-d4c6-4952-b7e7-ae9646b9724712022-09-12
68788-8221-6EA - Each68788-8221e11f46f4-baee-46e3-8f20-10a3e190511812022-09-12
68788-8221-8EA - Each68788-822173e18792-de23-409f-adb4-91a71240409f12022-09-12
68788-8221-9EA - Each68788-822173416b01-ecc8-4fee-9e71-bc05ea1f3d8e12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8221CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 5 package rows20250315_29ca9548-23b0-4c50-82cb-4f0564d7e065.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN29ca9548-23b0-4c50-82cb-4f0564d7e0655
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD29ca9548-23b0-4c50-82cb-4f0564d7e0655

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8221-26878882210220 TABLET, FILM COATED in 1 BOTTLE (68788-8221-2) 2022-09-090000-00-00NoNoCurrent
68788-8221-36878882210330 TABLET, FILM COATED in 1 BOTTLE (68788-8221-3) 2022-09-090000-00-00NoNoCurrent
68788-8221-66878882210660 TABLET, FILM COATED in 1 BOTTLE (68788-8221-6) 2022-09-090000-00-00NoNoCurrent
68788-8221-868788822108120 TABLET, FILM COATED in 1 BOTTLE (68788-8221-8) 2022-09-090000-00-00NoNoCurrent
68788-8221-96878882210990 TABLET, FILM COATED in 1 BOTTLE (68788-8221-9) 2022-09-090000-00-00NoNoCurrent