FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
72603-146
11-digit product format
726030146
Labeler code
72603
Product ID
72603-146_a2d07ec0-3718-40eb-9d0a-79c557c486b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
NorthStar Rx LLC
Application
ANDA214533
Marketing category
ANDA
Marketing start
2023-04-28
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
Rxcui896771

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
72603-146-01Labetalol Hydrochloride1 in 1 CARTONINJECTION, SOLUTION11
72603-146-01Labetalol Hydrochloride20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-146-01ML - Milliliter72603-146c26bbd3c-e41a-4b1d-9f2c-832308e0861112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-146LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [NORTHSTAR RX LLC]1Current NDC, 2 package rows20230429_a2d07ec0-3718-40eb-9d0a-79c557c486b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896771labetalol HCl 5 MG/ML Injectable SolutionPSNa2d07ec0-3718-40eb-9d0a-79c557c486b91
896771labetalol hydrochloride 5 MG/ML Injectable SolutionSCDa2d07ec0-3718-40eb-9d0a-79c557c486b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-146-01726030146011 VIAL, MULTI-DOSE in 1 CARTON (72603-146-01) / 20 mL in 1 VIAL, MULTI-DOSE2023-04-28NoNoHistorical