dexmedetomidine

Generic: dexmedetomidine

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

Drug Facts

Product Profile

Brand Name dexmedetomidine
Generic Name dexmedetomidine
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-505
Product ID 71288-505_74e25a75-2d63-4f39-b6d0-a73392bd1040
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204843
Listing Expiration 2026-12-31
Marketing Start 2019-01-18

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 71288505
Hyphenated Format 71288-505

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 (source: ndc)
Generic Name dexmedetomidine (source: ndc)
Application Number ANDA204843 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-505-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-505-02)
source: ndc

Packages (1)

71288-505-03 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-505-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-505-02)

Ingredients (1)

dexmedetomidine hydrochloride (100 ug/mL)

Linked Drug Pages (1)

DEXMEDETOMIDINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "74e25a75-2d63-4f39-b6d0-a73392bd1040", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["8fa36783-b94d-4084-8c41-40ee64192074"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (71288-505-03)  / 2 mL in 1 VIAL, SINGLE-DOSE (71288-505-02)", "package_ndc": "71288-505-03", "marketing_start_date": "20190118"}], "brand_name": "DEXMEDETOMIDINE", "product_id": "71288-505_74e25a75-2d63-4f39-b6d0-a73392bd1040", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "71288-505", "generic_name": "DEXMEDETOMIDINE", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMEDETOMIDINE", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA204843", "marketing_category": "ANDA", "marketing_start_date": "20190118", "listing_expiration_date": "20261231"}