FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
51655-440
11-digit product format
516550440
Labeler code
51655
Product ID
51655-440_7587c923-3dfe-4511-b49a-bec9ea331682
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA071611
Marketing category
ANDA
Marketing start
2014-11-24
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-440-522026-01-13C16284748780-19d75b9d0-4807-f424-e053-dadaa90a57ce02b6cb80-c903-466c-9608-fcbf1cb44fc0
51655-440-542026-01-13C16284748780-19d75b9d0-4807-f424-e053-dadaa90a57ce02b6cb80-c903-466c-9608-fcbf1cb44fc0
51655-440-522020-01-31C16284748780-19d75b9d0-4807-f424-e053-dadaa90a57ce02b6cb80-c903-466c-9608-fcbf1cb44fc0
51655-440-542020-01-31C16284748780-19d75b9d0-4807-f424-e053-dadaa90a57ce02b6cb80-c903-466c-9608-fcbf1cb44fc0

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-440CYCLOBENZAPRINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Legacy NDC20150401_02b6cb80-c903-466c-9608-fcbf1cb44fc0.zip