FDA.reportPublic FDA data

NDC 0143-9366-01 - Labetalol HCl in Sodium Chloride

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
0143-9366
Requested NDC
0143-9366-01
Package NDCs from labels
0143-9366-01, 0143-9366-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2025-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Labetalol HCl in Sodium Chloride - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2025-12-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9366-01Labetalol HCl in Dextrose200 mL in 1 BAGINJECTION2009
0143-9366-10Labetalol HCl in Dextrose10 in 1 BOXINJECTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9366LABETALOL HCL IN SODIUM CHLORIDE (LABETALOL HYDROCHLORIDE) INJECTION LABETALOL HCL IN DEXTROSE (LABETALOL HYDROCHLORIDE) INJECTION LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20250131_99a715a0-4579-410c-b102-7ef6fab8db55.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9366-01ML - Milliliter0143-9366dc2c5df0-e7bd-4967-b443-84f81a0ef79912021-05-05
0143-9366-10ML - Milliliter0143-93665f5ff719-8e9d-42b4-9c51-854907e5157812021-05-05

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 27 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fever-InfectionCHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUMNewton Laboratories, Inc.9d762268-8c30-8a86-e053-2a95a90a419c2025-01-27WarningsExact identifier
unii: 451W47IQ8X
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.5a94659f-b62a-41d8-81c0-87a68c02606d2025-01-27WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM59CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBestmade Natural Products2c763956-a1de-c8df-e063-6294a90a5c812025-01-24WarningsExact identifier
unii: 451W47IQ8X
Equate Sterile Saline MistSODIUM CHLORIDEWALMART INC.275ada29-8904-fe1e-e063-6394a90abe592025-01-24WarningsExact identifier
unii: 451W47IQ8X
Glucose and Sodium ChlorideDEXTROSE ANHYDROUS AND SODIUM CHLORIDEBaxter Healthcare Corporation1ba918d0-13d0-48bc-8742-658fc0eb47b62025-01-24Exact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation93aeac13-41de-4452-9f38-d6b4f38ada302025-01-24Exact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM33ACID FOLICD10, ACID PHOSD4, ARSENIC ALBD4, AVENA SATD3, BETA VULGD5, CHINA OFFD12, FERR METD5, NATRUM MURD5Bestmade Natural Productsef2beaff-5c94-de60-e053-2995a90ad7962025-01-23WarningsExact identifier
unii: 451W47IQ8X
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 2968PHW8QP
Bestmade Natural Products Nat Mur (Lactose-Free)NATRUM MURIATICUMBestmade Natural Products2c4b8827-e724-858a-e063-6394a90a3b4e2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Productse9fb280b-2f79-f268-e053-2995a90a732c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio2KALI PHOS, MAG PHOS, NAT MUR, NAT SULFBestmade Natural Productse9fc4f2f-a699-163f-e053-2995a90ab1fe2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Productsea22e5e7-491a-91ac-e053-2a95a90a44142025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Productsea233792-038f-39e7-e053-2995a90a20ad2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio11FERR PHOS, KALI MUR, KALI SULF, NAT MUR, NAT SULFBestmade Natural Productseaa202d7-4297-57ba-e053-2995a90a02952025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Productseab251db-c69a-572d-e053-2a95a90ab3a02025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio13CALC PHOS, KALI SULF, KALI PHOS, NAT MURBestmade Natural Productseab2e339-c9e9-3048-e053-2995a90ae1492025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Productseac26053-7c65-7c56-e053-2995a90a8e642025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFBestmade Natural Productseb3b0d9d-5f1c-8a3b-e053-2a95a90a0e1f2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio27MAG PHOS, CALC PHOS, KALI PHOS, CALC FLUORBestmade Natural Productseb420652-ec68-6b46-e053-2995a90af98c2025-01-22WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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