Guanfacine

Product NDC
0378-1160
11-digit product format
003781160
Labeler code
0378
Product ID
0378-1160_40f8fb73-2c25-41a6-974c-3c5bf8416516
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guanfacine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074796
Marketing category
ANDA
Marketing start
1997-01-27
Marketing end
0000-00-00
Substance
GUANFACINE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1160-01EA - Each0378-116065f7f235-fcff-4498-8765-c747311619b112012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1160-0100378116001100 TABLET in 1 BOTTLE (0378-1160-01) 100 tablet1997-01-270000-00-00NoNoCurrent