dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

Labeler: piramal critical care inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride
Generic Name dexmedetomidine hydrochloride
Labeler piramal critical care inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 4 ug/mL

Manufacturer
Piramal Critical Care Inc

Identifiers & Regulatory

Product NDC 66794-235
Product ID 66794-235_3f9d858b-fb67-25de-e063-6294a90a6776
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209307
Listing Expiration 2026-12-31
Marketing Start 2021-04-01

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 66794235
Hyphenated Format 66794-235

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 (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
  • 10 VIAL in 1 CARTON (66794-235-41) / 100 mL in 1 VIAL (66794-235-02)
source: ndc

Packages (1)

66794-235-41 10 VIAL in 1 CARTON (66794-235-41) / 100 mL in 1 VIAL (66794-235-02)

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": "3f9d858b-fb67-25de-e063-6294a90a6776", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909"], "spl_set_id": ["c958aeb4-69ce-c3e2-e053-2a95a90a6d8d"], "manufacturer_name": ["Piramal Critical Care Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (66794-235-41)  / 100 mL in 1 VIAL (66794-235-02)", "package_ndc": "66794-235-41", "marketing_start_date": "20210401"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "66794-235_3f9d858b-fb67-25de-e063-6294a90a6776", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "66794-235", "generic_name": "Dexmedetomidine Hydrochloride", "labeler_name": "Piramal Critical Care Inc", "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": "20210401", "listing_expiration_date": "20261231"}