FDA.reportPublic FDA data

NDC 0409-2339-24 - Labetalol Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0409-2339
Requested NDC
0409-2339-24
Package NDCs from labels
0409-2339-24, 0409-2339-34
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-06-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Labetalol Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-06-03HUMAN PRESCRIPTION DRUG LABEL
Labetalol HydrochlorideHospira, Inc.2021-05-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2339-24Labetalol Hydrochloride4 mL in 1 CARTRIDGEINJECTION, SOLUTION420
0409-2339-34Labetalol Hydrochloride10 in 1 PACKAGEINJECTION, SOLUTION1020
0409-2339-34Labetalol Hydrochloride1 in 1 CARTONINJECTION, SOLUTION120

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2339LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]20Current NDC, Legacy NDC, 3 package rows20210531_d3579d45-a964-40fe-e3a2-a3a997c8b7b9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2339-24ML - Milliliter0409-2339a5c8008c-66a8-48e4-9b63-293132b32a2512019-07-02
0409-2339-34ML - Milliliter0409-2339f791cad4-bc8b-42f8-b853-5eb984e9fef412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLC63db5b00-e864-4b2d-84f2-00bf35211b9b2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECoupler LLC5954cc5c-3e73-e039-e063-6394a90a7d6a2026-08-18Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Labetalol HydrochlorideLABETALOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy30281c4d-2fd1-167a-e063-6294a90a77c42026-06-30Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEOnesource Specialty Pharma Limited6cb2c117-584c-4440-acfb-e4b1af4dc5092026-06-29Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDESt. Mary's Medical Park Pharmacyed2293f8-2b82-c3db-e053-2995a90ad46c2026-06-22Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEREMEDYREPACK INC.5101b8dd-6148-465c-9bba-0209ce823fe52026-06-11Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBluePoint Laboratories Inc.63ede355-42ec-4c52-a941-51e5f6b35ed62026-06-08Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack9c3bb751-c425-43ff-b530-2460b568b6892026-06-05Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEA-S Medication Solutionsfffb7c59-ad92-4e74-850d-d94d42b7fdc92026-06-04Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBluePoint Laboratoriese4562c70-f245-4dbe-8fe1-0bb64a91a3152026-06-04Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLC1b96ddc9-d0c3-488a-a113-66491fd3d8992026-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA075239
ndc (package): 55154-4747-5
ndc (product): 55154-4747
rxcui: 1234256
spl id: 77254c29-bfa3-4f35-aaca-d9950c63545a
spl set id: 1b96ddc9-d0c3-488a-a113-66491fd3d899
unii: 1GEV3BAW9J
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEBryant Ranch Prepack04f9dcdf-4023-48ee-9e7d-ca9366d9db722026-05-22Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.