FDA.reportPublic FDA data

NDC 83301-0058-01 - 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
83301-0058
Requested NDC
83301-0058-01
Package NDCs from labels
83301-0058-1, 83301-0058-01
Manufacturer
Mullan Pharmaceutical Inc. | Gland Pharma Limited
Effective date
2025-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Labetalol Hydrochloride - Mullan Pharmaceutical Inc. | Gland Pharma LimitedMullan Pharmaceutical Inc. | Gland Pharma Limited2025-12-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0058-1Labetalol Hydrochloride1 in 1 CARTONINJECTION11
83301-0058-1Labetalol Hydrochloride20 mL in 1 VIAL, MULTI-DOSEINJECTION201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0058-1ML - Milliliter83301-005863162ec5-13c3-4e8b-99a4-92e68a43dffd12026-04-20

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
rxcui: 896771
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
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.