FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
68788-8706
11-digit product format
687888706
Labeler code
68788
Product ID
68788-8706_8c3c642d-7019-4437-bfab-d612345c7ddc
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
2024-07-01
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
68788-8706-2Cyclobenzaprine hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
68788-8706-3Cyclobenzaprine hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
68788-8706-6Cyclobenzaprine hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
68788-8706-8Cyclobenzaprine hydrochloride120 in 1 BOTTLETABLET, FILM COATED1203
68788-8706-9Cyclobenzaprine hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8706-2EA - Each68788-8706caac5586-3ea9-4800-a34c-237db0223db712024-09-09
68788-8706-3EA - Each68788-8706212aacdb-2087-425c-805f-ddbd543b5c3912024-09-09
68788-8706-6EA - Each68788-8706f0f7dca4-b161-4e4c-a34a-2f024d5991c112024-09-09
68788-8706-8EA - Each68788-870645d3600b-2d3c-4264-bc28-7cf8937473ca12024-09-09
68788-8706-9EA - Each68788-870698147022-7a1e-40fe-b706-d264999e3a3c12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8706CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20250315_ac8ae965-af50-41d3-8df5-ca6daf4bbd1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNac8ae965-af50-41d3-8df5-ca6daf4bbd1c3
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDac8ae965-af50-41d3-8df5-ca6daf4bbd1c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8706-26878887060220 TABLET, FILM COATED in 1 BOTTLE (68788-8706-2) 2024-07-01NoNoCurrent
68788-8706-36878887060330 TABLET, FILM COATED in 1 BOTTLE (68788-8706-3) 2024-07-01NoNoCurrent
68788-8706-66878887060660 TABLET, FILM COATED in 1 BOTTLE (68788-8706-6) 2024-07-01NoNoCurrent
68788-8706-868788870608120 TABLET, FILM COATED in 1 BOTTLE (68788-8706-8) 2024-07-01NoNoCurrent
68788-8706-96878887060990 TABLET, FILM COATED in 1 BOTTLE (68788-8706-9) 2024-07-01NoNoCurrent