dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride in sodium chloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride
Generic Name dexmedetomidine hydrochloride in sodium chloride
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 4 ug/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1711
Product ID 70121-1711_4751c8c4-1971-44bb-8311-fea390cc1b98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216604
Listing Expiration 2026-12-31
Marketing Start 2023-05-19

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 701211711
Hyphenated Format 70121-1711

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 in sodium chloride (source: ndc)
Application Number ANDA216604 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 15 POUCH in 1 CARTON (70121-1711-2) / 1 BAG in 1 POUCH / 50 mL in 1 BAG
  • 24 POUCH in 1 CARTON (70121-1711-9) / 1 BAG in 1 POUCH / 50 mL in 1 BAG
source: ndc

Packages (2)

70121-1711-2 15 POUCH in 1 CARTON (70121-1711-2) / 1 BAG in 1 POUCH / 50 mL in 1 BAG 70121-1711-9 24 POUCH in 1 CARTON (70121-1711-9) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

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": "4751c8c4-1971-44bb-8311-fea390cc1b98", "openfda": {"unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909"], "spl_set_id": ["4df8cc35-fc80-4438-b982-9c4b7d17bad2"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 POUCH in 1 CARTON (70121-1711-2)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG", "package_ndc": "70121-1711-2", "marketing_start_date": "20240108"}, {"sample": false, "description": "24 POUCH in 1 CARTON (70121-1711-9)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG", "package_ndc": "70121-1711-9", "marketing_start_date": "20230519"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "70121-1711_4751c8c4-1971-44bb-8311-fea390cc1b98", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "70121-1711", "generic_name": "Dexmedetomidine Hydrochloride in Sodium Chloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmedetomidine Hydrochloride", "active_ingredients": [{"name": "DEXMEDETOMIDINE HYDROCHLORIDE", "strength": "4 ug/mL"}], "application_number": "ANDA216604", "marketing_category": "ANDA", "marketing_start_date": "20230519", "listing_expiration_date": "20261231"}