dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride
Generic Name dexmedetomidine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 100 ug/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-421
Product ID 63323-421_56e0af34-aeb5-4b37-8c61-2e90b2c8ca6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201072
Listing Expiration 2026-12-31
Marketing Start 2015-09-18

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 63323421
Hyphenated Format 63323-421

Supplemental Identifiers

RxCUI
309710
UPC
0363323421014
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 ANDA201072 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (63323-421-02) / 2 mL in 1 VIAL (63323-421-01)
source: ndc

Packages (1)

63323-421-02 25 VIAL in 1 TRAY (63323-421-02) / 2 mL in 1 VIAL (63323-421-01)

Ingredients (1)

dexmedetomidine hydrochloride (100 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": "56e0af34-aeb5-4b37-8c61-2e90b2c8ca6c", "openfda": {"upc": ["0363323421014"], "unii": ["1018WH7F9I"], "rxcui": ["309710"], "spl_set_id": ["c1b8eb58-596b-481d-beb6-ba9d2237abf4"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-421-02)  / 2 mL in 1 VIAL (63323-421-01)", "package_ndc": "63323-421-02", "marketing_start_date": "20150918"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "63323-421_56e0af34-aeb5-4b37-8c61-2e90b2c8ca6c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "63323-421", "generic_name": "dexmedetomidine hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "100 ug/mL"}], "application_number": "ANDA201072", "marketing_category": "ANDA", "marketing_start_date": "20150918", "listing_expiration_date": "20261231"}