Labetalol Hydrochloride

Product NDC
0904-7111
11-digit product format
009047111
Labeler code
0904
Product ID
0904-7111_5eb2199a-cd19-48fa-9451-1c7940a0c8ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA207743
Marketing category
ANDA
Marketing start
2017-12-05
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7111-61EA - Each0904-7111c32a9640-c872-48a7-8973-505e76b76a0912021-07-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7111-6100904711161100 BLISTER PACK in 1 CARTON (0904-7111-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2017-12-050000-00-00NoNoCurrent