Labetalol HCL

Product NDC
63629-2214
11-digit product format
636292214
Labeler code
63629
Product ID
63629-2214_a4edb7b3-03f5-4307-a64c-d301ac5968c2
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
200 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
63629-2214-1EA - Each63629-2214366dc294-d8fb-4b41-967a-f2a1724a3fe412021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2214-163629221401100 TABLET, FILM COATED in 1 BOTTLE (63629-2214-1) 2021-02-080000-00-00NoNoCurrent