Kapvay

Product NDC
59212-658
11-digit product format
592120658
Labeler code
59212
Product ID
59212-658_8fe44e2f-89f7-4323-8b70-d830fc2542d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Concordia Pharmaceuticals Inc.
Application
NDA022331
Marketing category
NDA
Marketing start
2010-12-09
Marketing end
0000-00-00
Substance
CLONIDINE HYDROCHLORIDE
Active strength
0 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
59212-658-13EA - Each59212-658d10baa3e-c984-465e-82c5-3eecefc4e38512021-03-02
59212-658-60EA - Each59212-658075d59f6-39ca-4977-83c7-8aa281b4b67a12014-06-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-658-13592120658131 BOTTLE in 1 CARTON (59212-658-13) > 60 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-11-120000-00-00NoNoCurrent
59212-658-60592120658601 BOTTLE in 1 CARTON (59212-658-60) > 60 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2010-12-090000-00-00NoNoCurrent