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 6 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
PRECEDEXDEXMEDETOMIDINE HYDROCHLORIDEHenry Schein, Inc.9eb336de-5fa5-4b46-b40b-a7ca5a0864bd2026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 309710
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEGland Pharma Limitedf307de7e-a9ab-4734-abb7-66b4e112bc512026-05-20Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.548a88c0-afda-427e-75ac-5af0cfa2224c2026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 309710
unii: 1018WH7F9I
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEMylan Institutional LLCf140de5a-f13d-46b4-a742-049c63e474f52026-05-20Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDEAmneal Pharmaceuticals LLC4df8cc35-fc80-4438-b982-9c4b7d17bad22026-05-19Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DexmedetomidineDEXMEDETOMIDINEGland Pharma Limited714cc0d2-8a4c-40c0-8ef0-dcfde4c469892026-05-19Warnings, Adverse reactionsExact identifier
application number: ANDA202126
rxcui: 309710
unii: 1018WH7F9I
DexmedetomidineDEXMEDETOMIDINEMylan Institutional LLCebdfe2e8-30ca-4f18-935a-41bcbbce49372026-05-18Warnings, Adverse reactionsExact identifier
rxcui: 309710
unii: 1018WH7F9I
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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