FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
70518-3814
11-digit product format
705183814
Labeler code
70518
Product ID
70518-3814_43d081b5-edbb-f15e-e063-6394a90a6c2d
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
2023-08-01
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
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 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
70518-3814-0CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3011
70518-3814-1CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9011
70518-3814-2CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1011
70518-3814-3CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6011
70518-3814-4CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1511
70518-3814-5CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2011
70518-3814-6CYCLOBENZAPRINE HYDROCHLORIDE14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1411
70518-3814-7CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3011
70518-3814-8CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3814CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]8Current NDC, 9 package rows20240420_5d536e88-62be-45bd-bd09-0efc53fe12b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN5d536e88-62be-45bd-bd09-0efc53fe12b911
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD5d536e88-62be-45bd-bd09-0efc53fe12b911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3814-07051838140030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3814-0) 2023-08-01NoNoHistorical
70518-3814-17051838140190 in 1 BOTTLE, PLASTICHistorical
70518-3814-27051838140210 in 1 BOTTLE, PLASTICHistorical
70518-3814-37051838140360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3814-3) 2023-10-07NoNoHistorical
70518-3814-47051838140415 in 1 BOTTLE, PLASTICHistorical
70518-3814-57051838140520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3814-5) 2023-12-23NoNoHistorical
70518-3814-67051838140614 in 1 BOTTLE, PLASTICHistorical
70518-3814-77051838140730 in 1 BOTTLE, PLASTICHistorical
70518-3814-87051838140860 in 1 BOTTLE, PLASTICHistorical