dexmedetomidine hydrochloride in 0.9% sodium chloride

Generic: dexmedetomidine hydrochloride in 0.9% sodium chloride

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

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride in 0.9% sodium chloride
Generic Name dexmedetomidine hydrochloride in 0.9% sodium chloride
Labeler baxter healthcare company
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 400 ug/100mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 43066-557
Product ID 43066-557_d0910ea1-c3e1-44f8-b8b5-1f39ffd43290
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 43066557
Hyphenated Format 43066-557

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 in 0.9% sodium chloride (source: ndc)
Generic Name dexmedetomidine hydrochloride in 0.9% sodium chloride (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 (43066-557-12) / 100 mL in 1 BAG
source: ndc

Packages (1)

43066-557-12 12 BAG in 1 CARTON (43066-557-12) / 100 mL in 1 BAG

Ingredients (1)

dexmedetomidine hydrochloride (400 ug/100mL)

Linked Drug Pages (1)

DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d0910ea1-c3e1-44f8-b8b5-1f39ffd43290", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909"], "spl_set_id": ["aea9a3ad-c244-42be-9cd3-5df83fe2b522"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CARTON (43066-557-12)  / 100 mL in 1 BAG", "package_ndc": "43066-557-12", "marketing_start_date": "20190827"}], "brand_name": "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE", "product_id": "43066-557_d0910ea1-c3e1-44f8-b8b5-1f39ffd43290", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "43066-557", "generic_name": "DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "400 ug/100mL"}], "application_number": "ANDA208532", "marketing_category": "ANDA", "marketing_start_date": "20190827", "listing_expiration_date": "20271231"}