FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
70518-3415
11-digit product format
705183415
Labeler code
70518
Product ID
70518-3415_4f06e16a-e75e-e39d-e063-6394a90a120a
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
2022-04-29
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
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 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
70518-3415-0CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-3415-1CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
70518-3415-2CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
70518-3415-3CYCLOBENZAPRINE HYDROCHLORIDE12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1214
70518-3415-4CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
70518-3415-5CYCLOBENZAPRINE HYDROCHLORIDE14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1414
70518-3415-6CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3415-1EA - Each70518-34151e21b7e3-d341-414e-ac64-523a753470b212026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3415CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 7 package rows20240926_8bef97d4-1b92-4316-8733-7751d627230f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN8bef97d4-1b92-4316-8733-7751d627230f14
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD8bef97d4-1b92-4316-8733-7751d627230f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3415-07051834150030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3415-0) 2022-04-290000-00-00NoNoCurrent
70518-3415-17051834150190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3415-1) 2024-04-30NoNoHistorical
70518-3415-27051834150230 in 1 BOTTLE, PLASTICHistorical
70518-3415-37051834150312 in 1 BOTTLE, PLASTICHistorical
70518-3415-47051834150490 in 1 BOTTLE, PLASTICHistorical
70518-3415-57051834150514 in 1 BOTTLE, PLASTICHistorical
70518-3415-67051834150620 in 1 BOTTLE, PLASTICHistorical