dexmedetomidine hydrochloride

Generic: dexmedetomidine hydrochloride

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

Drug Facts

Product Profile

Brand Name dexmedetomidine hydrochloride
Generic Name dexmedetomidine hydrochloride
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexmedetomidine hydrochloride 4 ug/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1388
Product ID 70121-1388_795f643f-855c-4ba4-9bad-a96334c1a2fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207551
Listing Expiration 2026-12-31
Marketing Start 2020-05-20

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 701211388
Hyphenated Format 70121-1388

Supplemental Identifiers

RxCUI
1718906 1718909
UPC
0370121138914 0370121138815 0370121138884
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 ANDA207551 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 ug/mL
source: ndc
Packaging
  • 20 BOTTLE, GLASS in 1 CARTON (70121-1388-8) / 50 mL in 1 BOTTLE, GLASS (70121-1388-1)
source: ndc

Packages (1)

70121-1388-8 20 BOTTLE, GLASS in 1 CARTON (70121-1388-8) / 50 mL in 1 BOTTLE, GLASS (70121-1388-1)

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": "795f643f-855c-4ba4-9bad-a96334c1a2fb", "openfda": {"upc": ["0370121138914", "0370121138815", "0370121138884"], "unii": ["1018WH7F9I"], "rxcui": ["1718906", "1718909"], "spl_set_id": ["eb1ba463-ab42-4f49-9ebe-3ad5af108326"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BOTTLE, GLASS in 1 CARTON (70121-1388-8)  / 50 mL in 1 BOTTLE, GLASS (70121-1388-1)", "package_ndc": "70121-1388-8", "marketing_start_date": "20200520"}], "brand_name": "Dexmedetomidine Hydrochloride", "product_id": "70121-1388_795f643f-855c-4ba4-9bad-a96334c1a2fb", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "70121-1388", "generic_name": "Dexmedetomidine Hydrochloride", "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": "ANDA207551", "marketing_category": "ANDA", "marketing_start_date": "20200520", "listing_expiration_date": "20261231"}