CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
68788-7536
11-digit product format
687887536
Labeler code
68788
Product ID
68788-7536_19239f2d-e99b-4fb9-b822-5af69cfe0171
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7536-2EA - Each68788-7536b9a4dbb0-0a56-4b8a-bfdb-2694835fe04912020-01-03
68788-7536-3EA - Each68788-75368d8ecea1-9879-4faf-a101-f5deec2aa2df12020-01-03
68788-7536-6EA - Each68788-7536a51ac9be-333e-4f3c-8f65-e379e30a5c2a12020-01-03
68788-7536-9EA - Each68788-7536abfd2a4e-ef63-4ab0-a925-f1dcf67b694412020-01-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7536-06878875360010 TABLET, FILM COATED in 1 BOTTLE (68788-7536-0) 2019-10-250000-00-00NoNoCurrent
68788-7536-16878875360114 TABLET, FILM COATED in 1 BOTTLE (68788-7536-1) 2019-10-250000-00-00NoNoCurrent
68788-7536-26878875360220 TABLET, FILM COATED in 1 BOTTLE (68788-7536-2) 2019-10-250000-00-00NoNoCurrent
68788-7536-36878875360330 TABLET, FILM COATED in 1 BOTTLE (68788-7536-3) 2019-10-250000-00-00NoNoCurrent
68788-7536-56878875360515 TABLET, FILM COATED in 1 BOTTLE (68788-7536-5) 2019-10-250000-00-00NoNoCurrent
68788-7536-66878875360660 TABLET, FILM COATED in 1 BOTTLE (68788-7536-6) 2019-10-250000-00-00NoNoCurrent
68788-7536-868788753608120 TABLET, FILM COATED in 1 BOTTLE (68788-7536-8) 2019-10-250000-00-00NoNoCurrent
68788-7536-96878875360990 TABLET, FILM COATED in 1 BOTTLE (68788-7536-9) 2019-10-250000-00-00NoNoCurrent