precedex

Generic: dexmedetomidine hydrochloride

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name precedex
Generic Name dexmedetomidine hydrochloride
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-1638
Product ID 0409-1638_b9ce69ad-26a2-491a-b393-66712b6f3ec0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021038
Listing Expiration 2027-12-31
Marketing Start 2004-11-30

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 04091638
Hyphenated Format 0409-1638

Supplemental Identifiers

RxCUI
284397 309710 1718900 1718902 1718906 1718907 1718909 1718910 2396891 2396892
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 precedex (source: ndc)
Generic Name dexmedetomidine hydrochloride (source: ndc)
Application Number NDA021038 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (0409-1638-02) / 2 mL in 1 VIAL (0409-1638-32)
source: ndc

Packages (1)

0409-1638-02 25 VIAL in 1 TRAY (0409-1638-02) / 2 mL in 1 VIAL (0409-1638-32)

Ingredients (1)

dexmedetomidine hydrochloride (100 ug/mL)

Linked Drug Pages (1)

Precedex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b9ce69ad-26a2-491a-b393-66712b6f3ec0", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["284397", "309710", "1718900", "1718902", "1718906", "1718907", "1718909", "1718910", "2396891", "2396892"], "spl_set_id": ["548a88c0-afda-427e-75ac-5af0cfa2224c"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (0409-1638-02)  / 2 mL in 1 VIAL (0409-1638-32)", "package_ndc": "0409-1638-02", "marketing_start_date": "20041130"}], "brand_name": "Precedex", "product_id": "0409-1638_b9ce69ad-26a2-491a-b393-66712b6f3ec0", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "0409-1638", "generic_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Precedex", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "NDA021038", "marketing_category": "NDA", "marketing_start_date": "20041130", "listing_expiration_date": "20271231"}