FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride

Product NDC
57664-596
11-digit product format
576640596
Labeler code
57664
Product ID
57664-596_1086cd9a-8975-4c42-a120-f8b70c9a7bdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceuticals Industries, Inc.
Application
ANDA202126
Marketing category
ANDA
Marketing start
2015-04-08
Substance
DEXMEDETOMIDINE HYDROCHLORIDE
Active strength
100 ug/mL
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmedetomidine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE100 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui309710

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ec136f1-cd53-4b90-826e-3eaeec54dca0Product name220250401
acae4bed-c293-9f7e-61b9-d68b8475ed3aProduct name220230104
536fa340-f745-6c4e-1ad7-a3c414722bccProduct name920170706

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa4
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa4
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa4
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa4
309710dexmedeTOMIDine HCl 200 MCG in 2 ML InjectionPSN6937235f-ea25-4950-e053-2991aa0a9b743
3097102 ML dexmedetomidine 0.1 MG/ML InjectionSCD6937235f-ea25-4950-e053-2991aa0a9b743
309710dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML InjectionSY6937235f-ea25-4950-e053-2991aa0a9b743
309710dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML InjectionSY6937235f-ea25-4950-e053-2991aa0a9b743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-596-40576640596402 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
57664-596-505766405965025 VIAL, SINGLE-DOSE in 1 CARTON (57664-596-50) / 2 mL in 1 VIAL, SINGLE-DOSE (57664-596-40) 2015-04-080000-00-00NoNoCurrent