Cyclobenzaprine Hydrochloride

Product NDC
67296-1728
11-digit product format
672961728
Labeler code
67296
Product ID
67296-1728_b8dfb680-8aa0-5315-e053-2995a90aa59d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA090478
Marketing category
ANDA
Marketing start
2019-11-01
Marketing end
0000-00-00
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
2022-12-31
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
67296-1728-72023-01-30C16284748780-1f386c649-f3c1-0266-e053-dadaa90a7c1aCyclobenzaprine 5mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1728-7Cyclobenzaprine Hydrochloride7 in 1 BOTTLETABLET, FILM COATED72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1728CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [REDPHARM DRUG, INC.]2Legacy NDC, 1 package rows20210115_9718d17f-9c78-292a-e053-2a95a90a38c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN9718d17f-9c78-292a-e053-2a95a90a38c32
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD9718d17f-9c78-292a-e053-2a95a90a38c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1728-7672961728077 TABLET, FILM COATED in 1 BOTTLE (67296-1728-7) 2019-11-010000-00-00NoNoCurrent