FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
68788-8637
11-digit product format
687888637
Labeler code
68788
Product ID
68788-8637_085f15c8-a837-46e6-b587-c2e138e679c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213324
Marketing category
ANDA
Marketing start
2024-04-19
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
68788-8637-2Cyclobenzaprine hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
68788-8637-3Cyclobenzaprine hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
68788-8637-5Cyclobenzaprine hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
68788-8637-6Cyclobenzaprine hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
68788-8637-9Cyclobenzaprine hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8637-2EA - Each68788-86378cb2b724-9aad-4993-9eae-ec803c1a30ac12024-07-12
68788-8637-3EA - Each68788-8637cc14984d-e108-4f1b-8c72-ab3737dfa94112024-07-12
68788-8637-5EA - Each68788-86370a4243e6-8f68-4e91-86bb-4a9900dde1bc12024-07-12
68788-8637-6EA - Each68788-8637fb52aca9-c321-4d09-8daa-307518487a4e12024-07-12
68788-8637-9EA - Each68788-8637ce961899-24ce-4948-be09-f5e269d87a1912024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8637CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20250315_348c7ad4-b380-4b78-88f4-106b94079f52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN348c7ad4-b380-4b78-88f4-106b94079f523
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD348c7ad4-b380-4b78-88f4-106b94079f523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8637-26878886370220 TABLET, FILM COATED in 1 BOTTLE (68788-8637-2) 2024-04-19NoNoHistorical
68788-8637-36878886370330 TABLET, FILM COATED in 1 BOTTLE (68788-8637-3) 2024-04-19NoNoHistorical
68788-8637-56878886370515 TABLET, FILM COATED in 1 BOTTLE (68788-8637-5) 2024-04-19NoNoHistorical
68788-8637-66878886370660 TABLET, FILM COATED in 1 BOTTLE (68788-8637-6) 2024-04-19NoNoHistorical
68788-8637-96878886370990 TABLET, FILM COATED in 1 BOTTLE (68788-8637-9) 2024-04-19NoNoHistorical