FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
68788-8471
11-digit product format
687888471
Labeler code
68788
Product ID
68788-8471_5ca0afab-45a0-4a76-84b1-a2a3e6728867
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208170
Marketing category
ANDA
Marketing start
2023-06-29
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
68788-8471-2CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED204
68788-8471-3CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED304
68788-8471-6CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED604
68788-8471-8CYCLOBENZAPRINE HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1204
68788-8471-9CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8471-2EA - Each68788-8471a2e984fc-3c02-4170-bbfd-662f8a4ad06c12023-08-08
68788-8471-3EA - Each68788-84712c3940da-4fff-4f37-a853-bc107e5f70ef12023-08-08
68788-8471-6EA - Each68788-8471af3b9e84-e613-471d-8951-0757a62510a812023-08-08
68788-8471-8EA - Each68788-84718e1d7767-1a14-404b-a56e-61a64bb9d46c12023-08-08
68788-8471-9EA - Each68788-847199c575ff-a954-40ab-9ee3-fb65e0cbcf6512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8471CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 5 package rows20250315_e4e8bab3-c5e7-4d2b-9692-ee6c6799b120.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNe4e8bab3-c5e7-4d2b-9692-ee6c6799b1204
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDe4e8bab3-c5e7-4d2b-9692-ee6c6799b1204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8471-26878884710220 TABLET, FILM COATED in 1 BOTTLE (68788-8471-2) 2023-06-29NoNoHistorical
68788-8471-36878884710330 TABLET, FILM COATED in 1 BOTTLE (68788-8471-3) 2023-06-29NoNoHistorical
68788-8471-66878884710660 TABLET, FILM COATED in 1 BOTTLE (68788-8471-6) 2023-06-29NoNoHistorical
68788-8471-868788847108120 TABLET, FILM COATED in 1 BOTTLE (68788-8471-8) 2023-06-29NoNoHistorical
68788-8471-96878884710990 TABLET, FILM COATED in 1 BOTTLE (68788-8471-9) 2023-06-29NoNoHistorical