dexmedetomidine hydrochloride in 0.9% sodium chloride (25021-615)

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride in 0.9% sodium chloride

Generic Name dexmedetomidine hydrochloride

Labeler sagent pharmaceuticals

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

dexmedetomidine hydrochloride 4 ug/mL

Manufacturer

Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-615

Product ID 25021-615_18a919fe-92bd-4e01-a966-7334eb31b844

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA217308

Listing Expiration 2026-12-31

Marketing Start 2024-02-15

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 25021615

Hyphenated Format 25021-615

Supplemental Identifiers

RxCUI

1718906 1718909

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 in 0.9% sodium chloride (source: ndc)

Generic Name dexmedetomidine hydrochloride (source: ndc)

Application Number ANDA217308 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

4 ug/mL

source: ndc

Packaging

10 BOTTLE in 1 CARTON (25021-615-50) / 50 mL in 1 BOTTLE
10 BOTTLE in 1 CARTON (25021-615-51) / 100 mL in 1 BOTTLE

source: ndc

Packages (2)

25021-615-50 10 BOTTLE in 1 CARTON (25021-615-50) / 50 mL in 1 BOTTLE 25021-615-51 10 BOTTLE in 1 CARTON (25021-615-51) / 100 mL in 1 BOTTLE

Ingredients (1)

dexmedetomidine hydrochloride (4 ug/mL)

Linked Drug Pages (1)

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "18a919fe-92bd-4e01-a966-7334eb31b844", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909"], "spl_set_id": ["a99335d0-1e87-4180-bde3-cbb12bf91a52"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE in 1 CARTON (25021-615-50)  / 50 mL in 1 BOTTLE", "package_ndc": "25021-615-50", "marketing_start_date": "20240215"}, {"sample": false, "description": "10 BOTTLE in 1 CARTON (25021-615-51)  / 100 mL in 1 BOTTLE", "package_ndc": "25021-615-51", "marketing_start_date": "20240215"}], "brand_name": "Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride", "product_id": "25021-615_18a919fe-92bd-4e01-a966-7334eb31b844", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "25021-615", "generic_name": "dexmedetomidine hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "4 ug/mL"}], "application_number": "ANDA217308", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20261231"}