Cyclobenzaprine Hydrochloride

Product NDC
67296-1763
11-digit product format
672961763
Labeler code
67296
Product ID
67296-1763_d61cb415-4234-5d38-e053-2a95a90aeb5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA077563
Marketing category
ANDA
Marketing start
2006-04-04
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1763-72024-07-25C16284748780-11030e365-2db3-111a-e063-dadaa90a10e2Cyclobenzaprine 10mg tablets
67296-1763-72024-01-30C16284748780-11030e365-2db3-111a-e063-dadaa90a10e2Cyclobenzaprine 10mg tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1763-7Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1763CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20240727_b336d6ef-8f76-6225-e053-2a95a90a8f33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb336d6ef-8f76-6225-e053-2a95a90a8f333
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDb336d6ef-8f76-6225-e053-2a95a90a8f333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1763-76729617630715 TABLET, FILM COATED in 1 BOTTLE (67296-1763-7) 2006-04-040000-00-00NoNoCurrent