dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

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

Drug Facts

Product Profile

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

dexmedetomidine hydrochloride 4 ug/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-238
Product ID 68083-238_e2ace91b-c8f3-444a-8353-2a4e312ff9df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209307
Listing Expiration 2027-12-31
Marketing Start 2020-06-03

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 68083238
Hyphenated Format 68083-238

Supplemental Identifiers

RxCUI
1718906 1718909
UPC
0368083239015
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 hydrochloride (source: ndc)
Generic Name dexmedetomidine hydrochloride (source: ndc)
Application Number ANDA209307 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 20 VIAL in 1 CARTON (68083-238-20) / 50 mL in 1 VIAL
source: ndc

Packages (1)

68083-238-20 20 VIAL in 1 CARTON (68083-238-20) / 50 mL in 1 VIAL

Ingredients (1)

dexmedetomidine hydrochloride (4 ug/mL)

Linked Drug Pages (1)

Dexmedetomidine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e2ace91b-c8f3-444a-8353-2a4e312ff9df", "openfda": {"upc": ["0368083239015"], "unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909"], "spl_set_id": ["f307de7e-a9ab-4734-abb7-66b4e112bc51"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 VIAL in 1 CARTON (68083-238-20)  / 50 mL in 1 VIAL", "package_ndc": "68083-238-20", "marketing_start_date": "20200603"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "68083-238_e2ace91b-c8f3-444a-8353-2a4e312ff9df", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "68083-238", "generic_name": "Dexmedetomidine Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "4 ug/mL"}], "application_number": "ANDA209307", "marketing_category": "ANDA", "marketing_start_date": "20200603", "listing_expiration_date": "20271231"}