Labetalol hydrochloride

Product NDC
0904-5929
11-digit product format
009045929
Labeler code
0904
Product ID
0904-5929_a7d85fa2-a56a-4f45-952b-2ec6dc41c621
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075133
Marketing category
ANDA
Marketing start
2009-06-10
Marketing end
2021-12-31
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
0904-5929-61EA - Each0904-59290ffef1e5-5bff-4d61-8bd0-b7ec988edb4312012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5929-6100904592961100 BLISTER PACK in 1 CARTON (0904-5929-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2009-06-100000-00-00NoNoCurrent