Labetalol Hydrochloride

Product NDC
47781-586
11-digit product format
477810586
Labeler code
47781
Product ID
47781-586_31b2325f-63aa-a3ef-4b01-59e3ab3aba2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Alvogen Inc.
Application
ANDA090699
Marketing category
ANDA
Marketing start
2017-06-01
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
5 mg/mL
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
47781-586-29ML - Milliliter47781-586829b60e6-ab01-41d8-8cdb-53507e6288e412017-07-07
47781-586-56ML - Milliliter47781-586835dd71d-f238-43a8-9984-ba07ce5efe6812017-07-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-586-29477810586291 VIAL, MULTI-DOSE in 1 CARTON (47781-586-29) > 20 mL in 1 VIAL, MULTI-DOSE2017-06-010000-00-00NoNoCurrent
47781-586-56477810586561 VIAL, MULTI-DOSE in 1 CARTON (47781-586-56) > 40 mL in 1 VIAL, MULTI-DOSE2017-06-010000-00-00NoNoCurrent