Acebutolol Hydrochloride

Product NDC
0378-1200
11-digit product format
003781200
Labeler code
0378
Product ID
0378-1200_f046c034-21f5-4803-b4bd-29e22333bf89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acebutolol hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074288
Marketing category
ANDA
Marketing start
1995-04-24
Marketing end
0000-00-00
Substance
ACEBUTOLOL HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
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
0378-1200-01EA - Each0378-1200222367be-3d05-421a-b3d8-454e288108d312012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1200-0100378120001100 CAPSULE in 1 BOTTLE (0378-1200-01) 100 capsule1995-04-240000-00-00NoNoCurrent