Labetalol Hydrochloride

Product NDC
24979-168
11-digit product format
249790168
Labeler code
24979
Product ID
24979-168_03d305c1-fb1e-4c39-b743-157ae33343dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TWi Pharmaceuticals, Inc.
Application
ANDA209603
Marketing category
ANDA
Marketing start
2018-08-01
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
100 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
24979-168-01EA - Each24979-1680a55d99f-009b-4802-bf17-abd7932e235d12018-10-11
24979-168-02EA - Each24979-1689b91e9a5-ef3d-4fce-acf6-597987ed2eec12018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-168-0124979016801100 TABLET, FILM COATED in 1 BOTTLE (24979-168-01) 2018-08-010000-00-00NoNoCurrent
24979-168-0224979016802500 TABLET, FILM COATED in 1 BOTTLE (24979-168-02) 2018-08-010000-00-00NoNoCurrent
24979-168-062497901680630 TABLET, FILM COATED in 1 BOTTLE (24979-168-06) 2018-08-010000-00-00NoNoCurrent