FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
70518-2611
11-digit product format
705182611
Labeler code
70518
Product ID
70518-2611_4e0509b1-7a77-6554-e063-6394a90a6522
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208170
Marketing category
ANDA
Marketing start
2020-03-03
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
70518-2611-0CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6013
70518-2611-1CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013
70518-2611-2CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013
70518-2611-3CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2013
70518-2611-4CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2611CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 5 package rows20250322_f2eb32c3-3da0-4938-9ed9-ea8420450fde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf2eb32c3-3da0-4938-9ed9-ea8420450fde13
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf2eb32c3-3da0-4938-9ed9-ea8420450fde13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2611-07051826110060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2611-0) 2020-03-030000-00-00NoNoCurrent
70518-2611-17051826110190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2611-1) 2020-03-100000-00-00NoNoCurrent
70518-2611-27051826110230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2611-2) 2020-11-170000-00-00NoNoCurrent
70518-2611-37051826110320 in 1 BOTTLE, PLASTICHistorical
70518-2611-47051826110490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2611-4) 2024-11-08NoNoHistorical