dexmedetomidine

Generic: dexmedetomidine

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine
Generic Name dexmedetomidine
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-527
Product ID 68083-527_72a287de-a53d-464e-9294-ff59945e1e73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202126
Listing Expiration 2027-12-31
Marketing Start 2021-06-28

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 68083527
Hyphenated Format 68083-527

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 ANDA202126 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL
source: ndc

Packages (1)

68083-527-25 25 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL

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": "72a287de-a53d-464e-9294-ff59945e1e73", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["714cc0d2-8a4c-40c0-8ef0-dcfde4c46989"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68083-527-25)  / 2 mL in 1 VIAL", "package_ndc": "68083-527-25", "marketing_start_date": "20210628"}], "brand_name": "Dexmedetomidine", "product_id": "68083-527_72a287de-a53d-464e-9294-ff59945e1e73", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "68083-527", "generic_name": "Dexmedetomidine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA202126", "marketing_category": "ANDA", "marketing_start_date": "20210628", "listing_expiration_date": "20271231"}