Cyclobenzaprine Hydrochloride

Product NDC
69176-300
11-digit product format
691760300
Labeler code
69176
Product ID
69176-300_352f7cf7-c592-364b-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TMIG 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
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69176-300-902020-01-31C16284748780-19d75b9d0-9a4e-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69176-300-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69176-300CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [TMIG INC]1Legacy NDC, 1 package rows20160616_352f7cf7-c591-364b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN352f7cf7-c591-364b-e054-00144ff88e881
828348cyclobenzaprine HCl 10 MG Oral TabletPSN35dc3f7b-43d5-6203-e054-00144ff88e881
310431gabapentin 300 MG Oral CapsulePSN35dc3f7b-43d5-6203-e054-00144ff88e881
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD352f7cf7-c591-364b-e054-00144ff88e881
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD35dc3f7b-43d5-6203-e054-00144ff88e881
310431gabapentin 300 MG Oral CapsuleSCD35dc3f7b-43d5-6203-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69176-300-906917603009090 in 1 BOTTLE, PLASTICHistorical