NDC 67457-198

Ultiva

Remifentanil Hydrochloride

Ultiva is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Remifentanil Hydrochloride.

• Product ID: 67457-198_6daaa2d2-b002-40d3-8a4b-59a460b46053
• NDC: 67457-198
• Product Type: Human Prescription Drug
• Proprietary Name: Ultiva
• Generic Name: Remifentanil Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1996-11-06
• Marketing Category: NDA / NDA
• Application Number: NDA020630
• Labeler Name: Mylan Institutional LLC
• Substance Name: REMIFENTANIL HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 67457-198-03

10 VIAL, GLASS in 1 CARTON (67457-198-03) > 3 mL in 1 VIAL, GLASS (67457-198-00)

• Marketing Start Date: 1996-11-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-198-98 [67457019898]

Ultiva INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020630
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-19

NDC 67457-198-99 [67457019899]

Ultiva INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020630
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-19

NDC 67457-198-00 [67457019800]

Ultiva INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020630
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-12-19

NDC 67457-198-05 [67457019805]

Ultiva INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020630
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1996-11-06

NDC 67457-198-10 [67457019810]

Ultiva INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020630
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1996-11-06

NDC 67457-198-03 [67457019803]

Ultiva INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020630
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1996-11-06

Drug Details

Active Ingredients

Ingredient	Strength
REMIFENTANIL HYDROCHLORIDE	1 mg/mL

OpenFDA Data

• SPL SET ID: dbc63b6e-f8c5-4fd0-8ec3-4f5e19125313
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • 5V444H5WIC
• RxNorm Concept Unique ID - RxCUI:
  • 1729578
  • 1729581
  • 1729712
  • 1729586
  • 1729710
  • 1729584

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

NDC Crossover Matching brand name "Ultiva" or generic name "Remifentanil Hydrochloride"

NDC	Brand Name	Generic Name
67457-198	Ultiva	Remifentanil Hydrochloride
67457-912	Ultiva	Remifentanil Hydrochloride
67457-913	Ultiva	Remifentanil Hydrochloride
67457-914	Ultiva	Remifentanil Hydrochloride
0143-9391	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE
0143-9392	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE
0143-9393	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE
63323-723	Remifentanil Hydrochloride	Remifentanil Hydrochloride
63323-724	Remifentanil Hydrochloride	Remifentanil Hydrochloride
63323-725	Remifentanil Hydrochloride	Remifentanil Hydrochloride
68475-505	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE
68475-506	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE
68475-507	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE