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 18 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC27dbf0bf-c273-2108-e063-6394a90a0a092025-11-10WarningsExact identifier
unii: 451W47IQ8X
AZO Yeast PlusCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURi-Health, Inc.22845cac-8011-4ea8-b35e-b72973eddb442025-11-07WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHenry Schein, Inc.2e81ffca-05c6-4fa0-8911-4b3cbfa713512025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.d8b8d796-bfba-42af-a859-99d7768715582025-11-07Adverse reactionsExact identifier
unii: 451W47IQ8X
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.31188cdf-7bc8-4d78-bfaf-c1dc9f851fd42025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.d3d29c8f-c326-4097-814a-7f4e08c670682025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.01721071-af03-4894-95c1-10b8bc64b8882025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DEXMEDETOMIDINEDEXMEDETOMIDINEProPharma Distribution42dab90e-68c1-bed1-e063-6294a90a4b0c2025-11-05Warnings, Adverse reactionsExact identifier
rxcui: 309710
unii: 1018WH7F9I
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.f6d82772-638c-4584-b9d3-8833669f59632025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEProPharma Distribution42caba25-dd87-040c-e063-6294a90a7a122025-11-04Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Com-Pare2 Dual Yeast Relief Plus Multi-symptom FormulaCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULPHURTRP Company42b6b9b9-a673-0bba-e063-6394a90a88662025-11-03WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEICU Medical Inc.d8ee14e9-6733-4813-9f21-2b043a5f71882025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEICU Medical Inc.4555b1bf-6d97-4798-a63d-6d34291c85ce2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.9dd1c001-73b3-41d4-9a96-61f6ad3a5dc32025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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