Cyclobenzaprine Hydrochloride

Product NDC
67296-1208
11-digit product format
672961208
Labeler code
67296
Product ID
67296-1208_9c9f179f-87b6-0a99-e053-2995a90a4eba
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
2007-02-28
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
2021-12-31
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
67296-1208-1Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED103
67296-1208-2Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
67296-1208-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
67296-1208-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
67296-1208-7Cyclobenzaprine Hydrochloride5 in 1 BOTTLETABLET, FILM COATED53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1208CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 5 package rows20200123_4f1e0ef0-5669-0cb8-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4f1e0ef0-5669-0cb8-e054-00144ff88e883
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4f1e0ef0-5669-0cb8-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1208-16729612080110 TABLET, FILM COATED in 1 BOTTLE (67296-1208-1) 2007-02-280000-00-00NoNoCurrent
67296-1208-26729612080220 TABLET, FILM COATED in 1 BOTTLE (67296-1208-2) 2007-02-280000-00-00NoNoCurrent
67296-1208-36729612080330 TABLET, FILM COATED in 1 BOTTLE (67296-1208-3) 2007-02-280000-00-00NoNoCurrent
67296-1208-56729612080515 TABLET, FILM COATED in 1 BOTTLE (67296-1208-5) 2007-02-280000-00-00NoNoCurrent
67296-1208-7672961208075 TABLET, FILM COATED in 1 BOTTLE (67296-1208-7) 2007-02-280000-00-00NoNoCurrent