Cyclobenzaprine hydrochloride

Product NDC
52817-190
11-digit product format
528170190
Labeler code
52817
Product ID
52817-190_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
5 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
52817-190-10EA - Each52817-1909db3bb65-3a67-4820-b943-a7cfd3e40e8512017-08-11
52817-190-50EA - Each52817-19072b8bf29-c28a-4c99-a510-25bc7dd0918012017-08-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-190-00528170190001000 TABLET in 1 BOTTLE (52817-190-00) 1000 tablet2017-08-090000-00-00NoNoCurrent
52817-190-1052817019010100 TABLET in 1 BOTTLE (52817-190-10) 100 tablet2017-08-090000-00-00NoNoCurrent
52817-190-5052817019050500 TABLET in 1 BOTTLE (52817-190-50) 500 tablet2017-08-090000-00-00NoNoCurrent