Cyclobenzaprine hydrochloride

Product NDC
52817-191
11-digit product format
528170191
Labeler code
52817
Product ID
52817-191_14722df1-fa89-43f3-acd5-864f14df7fdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA073541
Marketing category
ANDA
Marketing start
2017-08-09
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-191-00EA - Each52817-19106f136eb-07ea-48c3-85d1-87ef37c7b5b412017-08-11
52817-191-10EA - Each52817-191c6c4bb67-c806-431d-b73e-0870f6b27f3b12017-08-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-191-00528170191001000 TABLET in 1 BOTTLE (52817-191-00) 1000 tablet2017-08-090000-00-00NoNoCurrent
52817-191-1052817019110100 TABLET in 1 BOTTLE (52817-191-10) 100 tablet2017-08-090000-00-00NoNoCurrent
52817-191-5052817019150500 TABLET in 1 BOTTLE (52817-191-50) 500 tablet2017-08-090000-00-00NoNoCurrent