dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

Labeler: baxter healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride
Generic Name dexmedetomidine hydrochloride
Labeler baxter healthcare company
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 400 ug/100mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 43066-565
Product ID 43066-565_18385e15-6a52-4aec-b152-1cc136179bf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208532
Listing Expiration 2027-12-31
Marketing Start 2019-08-27

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 43066565
Hyphenated Format 43066-565

Supplemental Identifiers

RxCUI
1718906 1718909
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 ANDA208532 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 400 ug/100mL
source: ndc
Packaging
  • 12 BAG in 1 CARTON (43066-565-12) / 100 mL in 1 BAG
source: ndc

Packages (1)

43066-565-12 12 BAG in 1 CARTON (43066-565-12) / 100 mL in 1 BAG

Ingredients (1)

dexmedetomidine hydrochloride (400 ug/100mL)

Linked Drug Pages (1)

DEXMEDETOMIDINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "18385e15-6a52-4aec-b152-1cc136179bf4", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909"], "spl_set_id": ["32242f34-6e2b-4098-bd8e-3d55162f31b5"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CARTON (43066-565-12)  / 100 mL in 1 BAG", "package_ndc": "43066-565-12", "marketing_start_date": "20190827"}], "brand_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "product_id": "43066-565_18385e15-6a52-4aec-b152-1cc136179bf4", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "43066-565", "generic_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMEDETOMIDINE HYDROCHLORIDE", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "400 ug/100mL"}], "application_number": "ANDA208532", "marketing_category": "ANDA", "marketing_start_date": "20190827", "listing_expiration_date": "20271231"}