dexmedetomidine hcl

Generic: dexmedetomidine hcl

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine hcl
Generic Name dexmedetomidine hcl
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9532
Product ID 0143-9532_27ff2cf4-825d-4e29-bd8d-ffccffa13c74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205046
Listing Expiration 2026-12-31
Marketing Start 2017-04-26

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 01439532
Hyphenated Format 0143-9532

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 hcl (source: ndc)
Generic Name dexmedetomidine hcl (source: ndc)
Application Number ANDA205046 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0143-9532-25) / 2 mL in 1 VIAL (0143-9532-01)
source: ndc

Packages (1)

0143-9532-25 25 VIAL in 1 CARTON (0143-9532-25) / 2 mL in 1 VIAL (0143-9532-01)

Ingredients (1)

dexmedetomidine hydrochloride (100 ug/mL)

Linked Drug Pages (1)

Dexmedetomidine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "27ff2cf4-825d-4e29-bd8d-ffccffa13c74", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["de6f01a2-9f2d-4c68-9c02-06643704acb1"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0143-9532-25)  / 2 mL in 1 VIAL (0143-9532-01)", "package_ndc": "0143-9532-25", "marketing_start_date": "20170426"}], "brand_name": "Dexmedetomidine HCl", "product_id": "0143-9532_27ff2cf4-825d-4e29-bd8d-ffccffa13c74", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "0143-9532", "generic_name": "Dexmedetomidine HCl", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine HCl", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA205046", "marketing_category": "ANDA", "marketing_start_date": "20170426", "listing_expiration_date": "20261231"}