Tizanidne hydrochloride

Product NDC
68788-7962
11-digit product format
687887962
Labeler code
68788
Product ID
68788-7962_d6d3b80d-b234-446b-ae35-e84366caeab4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidne Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA212196
Marketing category
ANDA
Marketing start
2021-07-19
Marketing end
0000-00-00
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
6 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [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
68788-7962-1EA - Each68788-796257b1303c-5c95-4b47-94d7-0d0008f1c3aa12021-08-05
68788-7962-3EA - Each68788-7962fe33ebc7-bb2a-4fe4-9b21-43949239de8612021-08-05
68788-7962-6EA - Each68788-79629e473b1e-f774-4559-b816-5a04fb60444b12021-08-05
68788-7962-9EA - Each68788-79629c5d12cd-6191-40a9-961a-28bfb8205d1612021-08-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7962-168788796201100 CAPSULE in 1 BOTTLE (68788-7962-1) 100 capsule2021-07-190000-00-00NoNoCurrent
68788-7962-36878879620330 CAPSULE in 1 BOTTLE (68788-7962-3) 30 capsule2021-07-190000-00-00NoNoCurrent
68788-7962-66878879620660 CAPSULE in 1 BOTTLE (68788-7962-6) 60 capsule2021-07-190000-00-00NoNoCurrent
68788-7962-96878879620990 CAPSULE in 1 BOTTLE (68788-7962-9) 90 capsule2021-07-190000-00-00NoNoCurrent