Labetalol HCL

Product NDC
63629-9185
11-digit product format
636299185
Labeler code
63629
Product ID
63629-9185_b32a345f-c892-494c-be87-8c2a2b17a3f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200908
Marketing category
ANDA
Marketing start
2012-07-24
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9185-1EA - Each63629-918559ed293f-08e9-4371-88fe-50f4d27b101412022-09-12
63629-9185-2EA - Each63629-91855f612101-b32e-4e77-ad24-dcf65748250c12022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9185-163629918501500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9185-1) 2022-08-030000-00-00NoNoCurrent
63629-9185-263629918502100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9185-2) 2022-08-030000-00-00NoNoCurrent