Cyclobenzaprine Hydrochloride

Product NDC
67296-1893
11-digit product format
672961893
Labeler code
67296
Product ID
67296-1893_2c631fa5-2dbd-5a58-e063-6394a90ab1e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA078643
Marketing category
ANDA
Marketing start
2008-09-26
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride
Listing expiration
2026-12-31

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
67296-1893-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
67296-1893-1Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED102
67296-1893-7Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1893CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG]4Current NDC, 1 package rows20250125_09d35c34-11fa-3a5d-e063-6294a90ab172.zip
67296-1893CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG]2Current NDC, 2 package rows20250125_fc61c9f5-b0ec-3ff8-e053-6394a90adeb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN09d35c34-11fa-3a5d-e063-6294a90ab1724
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD09d35c34-11fa-3a5d-e063-6294a90ab1724
828348cyclobenzaprine HCl 10 MG Oral TabletPSNfc61c9f5-b0ec-3ff8-e053-6394a90adeb72
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDfc61c9f5-b0ec-3ff8-e053-6394a90adeb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67296-1893-16729618930110 TABLET, FILM COATED in 1 BOTTLE (67296-1893-1) 2008-09-26NoNoCurrent
67296-1893-36729618930330 TABLET, FILM COATED in 1 BOTTLE (67296-1893-3) 2008-09-26NoNoCurrent
67296-1893-76729618930715 TABLET, FILM COATED in 1 BOTTLE (67296-1893-7) 2008-09-26NoNoCurrent