CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
68788-7445
11-digit product format
687887445
Labeler code
68788
Product ID
68788-7445_0e85cfe2-a814-46b8-916c-8754ecf2e5b8
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
5 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
68788-7445-3EA - Each68788-7445b6ba64c9-d73c-4e97-b6b9-385e7f0d07de12020-03-10
68788-7445-6EA - Each68788-7445ff1e39e3-959c-43f2-9868-7596c408c33d12020-03-10
68788-7445-9EA - Each68788-74456cb8ff25-f117-44c2-a1c1-9e6957d220e512020-03-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7445-06878874450010 TABLET, FILM COATED in 1 BOTTLE (68788-7445-0) 2019-12-270000-00-00NoNoCurrent
68788-7445-16878874450114 TABLET, FILM COATED in 1 BOTTLE (68788-7445-1) 2019-12-270000-00-00NoNoCurrent
68788-7445-26878874450220 TABLET, FILM COATED in 1 BOTTLE (68788-7445-2) 2019-12-270000-00-00NoNoCurrent
68788-7445-36878874450330 TABLET, FILM COATED in 1 BOTTLE (68788-7445-3) 2019-12-270000-00-00NoNoCurrent
68788-7445-56878874450515 TABLET, FILM COATED in 1 BOTTLE (68788-7445-5) 2019-12-270000-00-00NoNoCurrent
68788-7445-66878874450660 TABLET, FILM COATED in 1 BOTTLE (68788-7445-6) 2019-12-270000-00-00NoNoCurrent
68788-7445-96878874450990 TABLET, FILM COATED in 1 BOTTLE (68788-7445-9) 2019-12-270000-00-00NoNoCurrent