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 4 ug/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-671
Product ID 63323-671_27411591-44a1-44c4-89c3-dd8c2687f0e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208129
Listing Expiration 2026-12-31
Marketing Start 2019-05-13

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 63323671
Hyphenated Format 63323-671

Supplemental Identifiers

RxCUI
1718900 1718906 1718909
UPC
0363323671020 0363323671051
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 ANDA208129 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 10 BOTTLE, GLASS in 1 CARTON (63323-671-00) / 100 mL in 1 BOTTLE, GLASS (63323-671-01)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-671-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-671-02)
  • 25 BOTTLE, GLASS in 1 CARTON (63323-671-50) / 50 mL in 1 BOTTLE, GLASS (63323-671-05)
source: ndc

Packages (3)

63323-671-00 10 BOTTLE, GLASS in 1 CARTON (63323-671-00) / 100 mL in 1 BOTTLE, GLASS (63323-671-01) 63323-671-20 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-671-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-671-02) 63323-671-50 25 BOTTLE, GLASS in 1 CARTON (63323-671-50) / 50 mL in 1 BOTTLE, GLASS (63323-671-05)

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": "27411591-44a1-44c4-89c3-dd8c2687f0e2", "openfda": {"upc": ["0363323671020", "0363323671051"], "unii": ["1018WH7F9I"], "rxcui": ["1718900", "1718906", "1718909"], "spl_set_id": ["4d5d2294-89a0-4b6f-aa00-d39a0393b6a8"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE, GLASS in 1 CARTON (63323-671-00)  / 100 mL in 1 BOTTLE, GLASS (63323-671-01)", "package_ndc": "63323-671-00", "marketing_start_date": "20190513"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-671-20)  / 20 mL in 1 VIAL, SINGLE-DOSE (63323-671-02)", "package_ndc": "63323-671-20", "marketing_start_date": "20190513"}, {"sample": false, "description": "25 BOTTLE, GLASS in 1 CARTON (63323-671-50)  / 50 mL in 1 BOTTLE, GLASS (63323-671-05)", "package_ndc": "63323-671-50", "marketing_start_date": "20190513"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "63323-671_27411591-44a1-44c4-89c3-dd8c2687f0e2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "63323-671", "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": "4 ug/mL"}], "application_number": "ANDA208129", "marketing_category": "ANDA", "marketing_start_date": "20190513", "listing_expiration_date": "20261231"}