precedex

Generic: dexmedetomidine hydrochloride

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

Drug Facts

Product Profile

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

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9938
Product ID 0404-9938_a852ab49-191f-4755-8035-a2979d8b6489
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021038
Listing Expiration 2026-12-31
Marketing Start 2022-01-13

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 04049938
Hyphenated Format 0404-9938

Supplemental Identifiers

RxCUI
284397 309710
UNII
1018WH7F9I

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
  • 1 VIAL in 1 BAG (0404-9938-02) / 2 mL in 1 VIAL
source: ndc

Packages (1)

0404-9938-02 1 VIAL in 1 BAG (0404-9938-02) / 2 mL in 1 VIAL

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": "a852ab49-191f-4755-8035-a2979d8b6489", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["284397", "309710"], "spl_set_id": ["9eb336de-5fa5-4b46-b40b-a7ca5a0864bd"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BAG (0404-9938-02)  / 2 mL in 1 VIAL", "package_ndc": "0404-9938-02", "marketing_start_date": "20220113"}], "brand_name": "PRECEDEX", "product_id": "0404-9938_a852ab49-191f-4755-8035-a2979d8b6489", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "0404-9938", "generic_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "labeler_name": "Henry Schein, 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": "20220113", "listing_expiration_date": "20261231"}