dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

Labeler: slayback pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride
Generic Name dexmedetomidine hydrochloride
Labeler slayback pharma llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 4 ug/mL

Manufacturer
Slayback Pharma LLC

Identifiers & Regulatory

Product NDC 71225-126
Product ID 71225-126_027725dc-e468-446c-b702-ab0f8a9e3be5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212791
Marketing Start 2019-12-06
Marketing End 2026-07-31

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 71225126
Hyphenated Format 71225-126

Supplemental Identifiers

RxCUI
1718900 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 ANDA212791 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (71225-126-04) / 20 mL in 1 VIAL (71225-126-01)
  • 20 BOTTLE in 1 CARTON (71225-126-05) / 50 mL in 1 BOTTLE (71225-126-02)
  • 10 BOTTLE in 1 CARTON (71225-126-06) / 100 mL in 1 BOTTLE (71225-126-03)
source: ndc

Packages (3)

71225-126-04 10 VIAL in 1 CARTON (71225-126-04) / 20 mL in 1 VIAL (71225-126-01) 71225-126-05 20 BOTTLE in 1 CARTON (71225-126-05) / 50 mL in 1 BOTTLE (71225-126-02) 71225-126-06 10 BOTTLE in 1 CARTON (71225-126-06) / 100 mL in 1 BOTTLE (71225-126-03)

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": "027725dc-e468-446c-b702-ab0f8a9e3be5", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["1718900", "1718906", "1718909"], "spl_set_id": ["e5d28ed8-e427-4850-81aa-98702d3b6a5d"], "manufacturer_name": ["Slayback Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (71225-126-04)  / 20 mL in 1 VIAL (71225-126-01)", "package_ndc": "71225-126-04", "marketing_end_date": "20260731", "marketing_start_date": "20211211"}, {"sample": false, "description": "20 BOTTLE in 1 CARTON (71225-126-05)  / 50 mL in 1 BOTTLE (71225-126-02)", "package_ndc": "71225-126-05", "marketing_end_date": "20260731", "marketing_start_date": "20191206"}, {"sample": false, "description": "10 BOTTLE in 1 CARTON (71225-126-06)  / 100 mL in 1 BOTTLE (71225-126-03)", "package_ndc": "71225-126-06", "marketing_end_date": "20260731", "marketing_start_date": "20191206"}], "brand_name": "DEXMEDETOMIDINE HYDROCHLORIDE", "product_id": "71225-126_027725dc-e468-446c-b702-ab0f8a9e3be5", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "71225-126", "generic_name": "dexmedetomidine hydrochloride", "labeler_name": "Slayback Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXMEDETOMIDINE HYDROCHLORIDE", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "4 ug/mL"}], "application_number": "ANDA212791", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "20191206"}