FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
0143-9183
11-digit product format
001439183
Labeler code
0143
Product ID
0143-9183_d0e3d92d-d96e-4d5e-98ca-3d18a4bc82d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA213330
Marketing category
NDA
Marketing start
2025-08-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Labetalol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1GEV3BAW9J
Rxcui2477889, 2479564, 2479566, 2479567

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77fProduct name220220311
759f1c41-9262-4238-8cee-33988631aaf4Product name520220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21Product name120210527
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9183-01Labetalol Hydrochloride4 mL in 1 VIALINJECTION, SOLUTION49
0143-9183-10Labetalol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9183-01ML - Milliliter0143-9183293fed39-6e61-4bb8-98b8-d4f65318ee5512025-10-14
0143-9183-10ML - Milliliter0143-918347d9a8ca-5ca5-4a6c-8263-ebf14db41d0f12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9183LABETALOL HCL IN SODIUM CHLORIDE (LABETALOL HYDROCHLORIDE) INJECTION LABETALOL HCL IN DEXTROSE (LABETALOL HYDROCHLORIDE) INJECTION LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, 2 package rows20250131_99a715a0-4579-410c-b102-7ef6fab8db55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2477889labetalol HCl 20 MG in 4 ML InjectionPSN99a715a0-4579-410c-b102-7ef6fab8db559
2479566labetalol hydrochloride 100 MG in 100 ML InjectionPSN99a715a0-4579-410c-b102-7ef6fab8db559
2479564labetalol hydrochloride 200 MG in 200 ML InjectionPSN99a715a0-4579-410c-b102-7ef6fab8db559
2479567labetalol hydrochloride 300 MG in 300 ML InjectionPSN99a715a0-4579-410c-b102-7ef6fab8db559
2479566100 ML labetalol hydrochloride 1 MG/ML InjectionSCD99a715a0-4579-410c-b102-7ef6fab8db559
2479564200 ML labetalol hydrochloride 1 MG/ML InjectionSCD99a715a0-4579-410c-b102-7ef6fab8db559
2479567300 ML labetalol hydrochloride 1 MG/ML InjectionSCD99a715a0-4579-410c-b102-7ef6fab8db559
24778894 ML labetalol hydrochloride 5 MG/ML InjectionSCD99a715a0-4579-410c-b102-7ef6fab8db559
2477889labetalol HCl 20 MG per 4 ML InjectionSY99a715a0-4579-410c-b102-7ef6fab8db559
2479566labetalol hydrochloride 100 MG per 100 ML InjectionSY99a715a0-4579-410c-b102-7ef6fab8db559
2479564labetalol hydrochloride 200 MG per 200 ML InjectionSY99a715a0-4579-410c-b102-7ef6fab8db559
2479567labetalol hydrochloride 300 MG per 300 ML InjectionSY99a715a0-4579-410c-b102-7ef6fab8db559

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9183-01001439183014 mL in 1 VIAL4 mlHistorical
0143-9183-100014391831010 VIAL in 1 CARTON (0143-9183-10) / 4 mL in 1 VIAL (0143-9183-01) 10 vial2025-08-28NoNoHistorical