dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

Labeler: sun pharmaceuticals industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride
Generic Name dexmedetomidine hydrochloride
Labeler sun pharmaceuticals industries, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Sun Pharmaceuticals Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-596
Product ID 57664-596_1086cd9a-8975-4c42-a120-f8b70c9a7bdb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202126
Listing Expiration 2026-12-31
Marketing Start 2015-04-08

Pharmacologic Class

Classes
adrenergic alpha2-agonists [moa] central alpha-2 adrenergic agonist [epc] general anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664596
Hyphenated Format 57664-596

Supplemental Identifiers

RxCUI
309710
UNII
1018WH7F9I

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dexmedetomidine hydrochloride (source: ndc)
Generic Name dexmedetomidine hydrochloride (source: ndc)
Application Number ANDA202126 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (57664-596-50) / 2 mL in 1 VIAL, SINGLE-DOSE (57664-596-40)
source: ndc

Packages (1)

57664-596-50 25 VIAL, SINGLE-DOSE in 1 CARTON (57664-596-50) / 2 mL in 1 VIAL, SINGLE-DOSE (57664-596-40)

Ingredients (1)

dexmedetomidine hydrochloride (100 ug/mL)

Linked Drug Pages (1)

Dexmedetomidine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1086cd9a-8975-4c42-a120-f8b70c9a7bdb", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa"], "manufacturer_name": ["Sun Pharmaceuticals Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (57664-596-50)  / 2 mL in 1 VIAL, SINGLE-DOSE (57664-596-40)", "package_ndc": "57664-596-50", "marketing_start_date": "20150408"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "57664-596_1086cd9a-8975-4c42-a120-f8b70c9a7bdb", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "57664-596", "generic_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "labeler_name": "Sun Pharmaceuticals Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA202126", "marketing_category": "ANDA", "marketing_start_date": "20150408", "listing_expiration_date": "20261231"}