Labetalol Hydrochloride

Product NDC
63629-9283
11-digit product format
636299283
Labeler code
63629
Product ID
63629-9283_3efaa056-6e31-4b5f-9b6a-94e6620df647
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075215
Marketing category
ANDA
Marketing start
2019-11-22
Marketing end
0000-00-00
Substance
LABETALOL
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
63629-9283-1EA - Each63629-9283433805b9-1985-4c18-b17f-e2b3fdd736e612022-07-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9283-163629928301500 TABLET, FILM COATED in 1 BOTTLE (63629-9283-1) 2022-06-060000-00-00NoNoCurrent