Cyclobenzaprine Hydrochloride

Product NDC
67296-0007
11-digit product format
672960007
Labeler code
67296
Product ID
67296-0007_3fb41bbb-ff28-22c6-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA071611
Marketing category
ANDA
Marketing start
1989-05-03
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
E
Listing certified through
2018-12-31
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
67296-0007-1Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET153
67296-0007-2Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET203
67296-0007-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0007CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]3Legacy NDC, 3 package rows20161025_3fb41bbb-ff27-22c6-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN3fb41bbb-ff27-22c6-e054-00144ff8d46c3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD3fb41bbb-ff27-22c6-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0007-16729600070115 in 1 BOTTLEHistorical
67296-0007-26729600070220 in 1 BOTTLEHistorical
67296-0007-36729600070330 in 1 BOTTLEHistorical