dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride
Generic Name dexmedetomidine hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 4 ug/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-617
Product ID 25021-617_56ca6ba0-864c-4360-8791-0bd8399b2a2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209307
Listing Expiration 2026-12-31
Marketing Start 2025-07-15

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 25021617
Hyphenated Format 25021-617

Supplemental Identifiers

RxCUI
1718909
UPC
0325021617823
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 BAG in 1 CARTON (25021-617-82) / 100 mL in 1 BAG
source: ndc

Packages (1)

25021-617-82 20 BAG in 1 CARTON (25021-617-82) / 100 mL in 1 BAG

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": "56ca6ba0-864c-4360-8791-0bd8399b2a2b", "openfda": {"upc": ["0325021617823"], "unii": ["1018WH7F9I"], "rxcui": ["1718909"], "spl_set_id": ["65885aef-faaf-4dec-a180-9a657f738bbc"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BAG in 1 CARTON (25021-617-82)  / 100 mL in 1 BAG", "package_ndc": "25021-617-82", "marketing_start_date": "20250715"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "25021-617_56ca6ba0-864c-4360-8791-0bd8399b2a2b", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "25021-617", "generic_name": "Dexmedetomidine Hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "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": "20250715", "listing_expiration_date": "20261231"}