Cyclobenzaprine Hydrochloride

Product NDC
67296-1524
11-digit product format
672961524
Labeler code
67296
Product ID
67296-1524_d61b8d69-9070-c423-e053-2995a90ab376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA077797
Marketing category
ANDA
Marketing start
2017-03-30
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1524-1Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED107
67296-1524-2Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED207
67296-1524-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
67296-1524-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED157
67296-1524-9Cyclobenzaprine Hydrochloride5 in 1 BOTTLETABLET, FILM COATED57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1524CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]7Legacy NDC, 5 package rows20240802_52a30c84-3234-0aa5-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN52a30c84-3234-0aa5-e054-00144ff88e887
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD52a30c84-3234-0aa5-e054-00144ff88e887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1524-16729615240110 TABLET, FILM COATED in 1 BOTTLE (67296-1524-1) 2017-03-300000-00-00NoNoCurrent
67296-1524-26729615240220 TABLET, FILM COATED in 1 BOTTLE (67296-1524-2) 2017-03-300000-00-00NoNoCurrent
67296-1524-36729615240330 TABLET, FILM COATED in 1 BOTTLE (67296-1524-3) 2017-03-300000-00-00NoNoCurrent
67296-1524-56729615240515 TABLET, FILM COATED in 1 BOTTLE (67296-1524-5) 2017-03-300000-00-00NoNoCurrent
67296-1524-9672961524095 TABLET, FILM COATED in 1 BOTTLE (67296-1524-9) 2017-03-300000-00-00NoNoCurrent