ultiva

Generic: remifentanil hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ultiva
Generic Name remifentanil hydrochloride
Labeler mylan institutional llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

remifentanil hydrochloride 1 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 72078-035
Product ID 72078-035_594087a1-25f2-4f68-aea6-ad7df40559ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020630
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-09-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72078035
Hyphenated Format 72078-035

Supplemental Identifiers

RxCUI
1729578 1729581 1729584 1729586 1729710 1729712
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 ultiva (source: ndc)
Generic Name remifentanil hydrochloride (source: ndc)
Application Number NDA020630 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (72078-035-02) / 5 mL in 1 VIAL, GLASS (72078-035-00)
source: ndc

Packages (1)

72078-035-02 10 VIAL, GLASS in 1 CARTON (72078-035-02) / 5 mL in 1 VIAL, GLASS (72078-035-00)

Ingredients (1)

remifentanil hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Ultiva ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "594087a1-25f2-4f68-aea6-ad7df40559ab", "openfda": {"unii": ["5V444H5WIC"], "rxcui": ["1729578", "1729581", "1729584", "1729586", "1729710", "1729712"], "spl_set_id": ["8b4c8696-e23e-4c51-a4d2-babab5bd945a"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (72078-035-02)  / 5 mL in 1 VIAL, GLASS (72078-035-00)", "package_ndc": "72078-035-02", "marketing_start_date": "20230918"}], "brand_name": "Ultiva", "product_id": "72078-035_594087a1-25f2-4f68-aea6-ad7df40559ab", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72078-035", "dea_schedule": "CII", "generic_name": "Remifentanil Hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ultiva", "active_ingredients": [{"name": "REMIFENTANIL HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "NDA020630", "marketing_category": "NDA", "marketing_start_date": "20230918", "listing_expiration_date": "20261231"}