FDA.reportPublic FDA data

NDC 57664-596-40 - Dexmedetomidine 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
57664-596
Requested NDC
57664-596-40
Package NDCs from labels
57664-596-40, 57664-596-50
Manufacturer
Medical Purchasing Solutions, LLC
Effective date
2023-05-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexmedetomidine Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-23HUMAN PRESCRIPTION DRUG LABEL
DEXMEDETOMIDINE - Sun Pharmaceuticals Industries, Inc. | GLAND PHARMA LIMITEDSun Pharmaceuticals Industries, Inc. | GLAND PHARMA LIMITED2018-08-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-596-40Dexmedetomidine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION24
57664-596-50Dexmedetomidine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-596DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [SUN PHARMACEUTICALS INDUSTRIES, INC.]4Current NDC, Legacy NDC, 2 package rows20180822_4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-596-40ML - Milliliter57664-59669bf0db0-bac9-485f-b8c1-de22358d8dad12015-10-02
57664-596-50ML - Milliliter57664-5967cc0a3d0-279f-482a-b635-2d2d37cea53812018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMEDETOMIDINE HYDROCHLORIDEACTIVE INGREDIENT1018WH7F9IDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [SUN PHARMACEUTICALS INDUSTRIES INC.]2
DEXMEDETOMIDINEACTIVE MOIETY67VB76HONODEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [SUN PHARMACEUTICALS INDUSTRIES INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [SUN PHARMACEUTICALS INDUSTRIES INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [SUN PHARMACEUTICALS INDUSTRIES INC.]2

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 44 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclease PMSESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICELaboratoires Boiron09ff0633-2992-4aba-96ed-45a69f3ee5892023-05-30WarningsExact identifier
unii: 451W47IQ8X
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLC6937235f-ea25-4950-e053-2991aa0a9b742023-05-23Warnings, Adverse reactionsExact identifier
application number: ANDA202126
ndc (package): 71872-7122-1
ndc (product): 71872-7122
rxcui: 309710
spl id: fc5dd4b0-0e31-858e-e053-6394a90a2714
spl set id: 6937235f-ea25-4950-e053-2991aa0a9b74
unii: 1018WH7F9I
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEMedical Purchasing Solutions, LLC8a0d24a9-d02a-0379-e053-2a95a90af7122023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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.00478787-ccec-4101-a0da-fd337037c3ee2023-05-12WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexmedetomidine HClDEXMEDETOMIDINE HCLMedical Purchasing Solutions, LLCada70a68-3e52-4b94-e053-2995a90aa1e02023-05-03Warnings, Adverse reactionsExact identifier
rxcui: 309710
unii: 1018WH7F9I
Natrum MuriaticumNATRIUM MURIATICUMTrue Botanica, LLC7d2d9129-8683-484d-e053-2a91aa0a6f8f2023-05-01WarningsExact identifier
unii: 451W47IQ8X
CosmestatALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUMEnergique, Inc.edc8eb65-84b3-433f-8aad-7a741f5637182023-04-17WarningsExact identifier
unii: 451W47IQ8X
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: 451W47IQ8X
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: 451W47IQ8X
AnxietyBORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTIINutritional Specialties, Inc.657ed32f-3ac7-4806-96b4-4c7aa0f65e7f2023-04-03WarningsExact identifier
unii: 451W47IQ8X
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum muriaticumSODIUM CHLORIDEBoiron1ef4a040-7bee-11e6-8371-424c583030312023-02-20Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645e304-a71b-5cba-e053-2a91aa0a2d882023-02-20Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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