remifentanil hydrochloride

Generic: remifentanil hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name remifentanil hydrochloride
Generic Name remifentanil hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

remifentanil hydrochloride 5 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9393
Product ID 0143-9393_5c5e498b-d829-4f78-bcca-466631014767
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210594
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-05-15

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439393
Hyphenated Format 0143-9393

Supplemental Identifiers

RxCUI
1729578 1729584 1729710
UNII
5V444H5WIC

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 remifentanil hydrochloride (source: ndc)
Generic Name remifentanil hydrochloride (source: ndc)
Application Number ANDA210594 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9393-10) / 10 mL in 1 VIAL (0143-9393-01)
source: ndc

Packages (1)

0143-9393-10 10 VIAL in 1 CARTON (0143-9393-10) / 10 mL in 1 VIAL (0143-9393-01)

Ingredients (1)

remifentanil hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

REMIFENTANIL HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5c5e498b-d829-4f78-bcca-466631014767", "openfda": {"unii": ["5V444H5WIC"], "rxcui": ["1729578", "1729584", "1729710"], "spl_set_id": ["9d289052-1eb6-4ba2-a3ca-d2e542a052ae"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9393-10)  / 10 mL in 1 VIAL (0143-9393-01)", "package_ndc": "0143-9393-10", "marketing_start_date": "20210515"}], "brand_name": "REMIFENTANIL HYDROCHLORIDE", "product_id": "0143-9393_5c5e498b-d829-4f78-bcca-466631014767", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0143-9393", "dea_schedule": "CII", "generic_name": "REMIFENTANIL HYDROCHLORIDE", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "REMIFENTANIL HYDROCHLORIDE", "active_ingredients": [{"name": "REMIFENTANIL HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA210594", "marketing_category": "ANDA", "marketing_start_date": "20210515", "listing_expiration_date": "20261231"}