Labetalol HCl

Product NDC
0185-0117
11-digit product format
001850117
Labeler code
0185
Product ID
0185-0117_a4c308a8-e7f2-4f2f-b2f5-2cf74022a372
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA075113
Marketing category
ANDA
Marketing start
1998-08-04
Marketing end
2023-09-30
Substance
LABETALOL HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0117-01EA - Each0185-0117e60f4860-890a-46bf-a3b2-ea15a79d090c12012-07-24
0185-0117-05EA - Each0185-0117a0ce7742-613e-4026-b3c6-d058bf423bf912012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-0117-0100185011701100 TABLET, FILM COATED in 1 BOTTLE (0185-0117-01) 1998-08-040000-00-00NoNoCurrent
0185-0117-0500185011705500 TABLET, FILM COATED in 1 BOTTLE (0185-0117-05) 1998-08-040000-00-00NoNoCurrent
0185-0117-10001850117101000 TABLET, FILM COATED in 1 BOTTLE (0185-0117-10) 1998-08-040000-00-00NoNoCurrent