FDA.reportPublic FDA data

NDC 63323-421-01 - 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
63323-421
Requested NDC
63323-421-01
Package NDCs from labels
63323-421-01, 63323-421-02, 63323-421-16
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexmedetomidine Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-09-22HUMAN PRESCRIPTION DRUG LABEL
Dexmedetomidine Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2020-01-22Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-421-01Dexmedetomidine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION29
63323-421-02Dexmedetomidine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-421DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 2 package rows20221123_c1b8eb58-596b-481d-beb6-ba9d2237abf4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-421-01ML - Milliliter63323-4215be31c1c-261b-4fad-adc2-48c92f3e5d1812024-04-05
63323-421-02ML - Milliliter63323-421fe5184cd-2d05-4b8d-942b-eb45f5d8273c12015-12-02
63323-421-16ML - Milliliter63323-4211270b335-9970-468c-8a10-dd716c0f16af12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMEDETOMIDINE HYDROCHLORIDEACTIVE INGREDIENT1018WH7F9IDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
DEXMEDETOMIDINEACTIVE MOIETY67VB76HONODEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]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 16 of 49 · 965 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
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
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
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.9dd1c001-73b3-41d4-9a96-61f6ad3a5dc32025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.3cfdeee0-ff14-4341-8396-b11c2a037c602025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.5f372b75-d7a4-471e-8ac6-290040fc84b02025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.243fe8fc-996a-4855-8daf-069628e547c42025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEICU Medical Inc.d310d170-5eeb-471b-af1a-0e845001d21d2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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