NDC 64693-002

INOmax

Nitric Oxide

INOmax is a Respiratory (inhalation) Gas in the Human Prescription Drug category. It is labeled and distributed by Ino Therapeutics Llc. The primary component is Nitric Oxide.

• Product ID: 64693-002_6bb422a7-69d8-4ded-96b6-c8632c097ad8
• NDC: 64693-002
• Product Type: Human Prescription Drug
• Proprietary Name: INOmax
• Generic Name: Nitric Oxide
• Dosage Form: Gas
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 1999-12-23
• Marketing Category: NDA / NDA
• Application Number: NDA020845
• Labeler Name: INO THERAPEUTICS LLC
• Substance Name: NITRIC OXIDE
• Active Ingredient Strength: 1 mg/L
• Pharm Classes: Vasodilation [PE],Vasodilator [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 64693-002-01

1 CYLINDER in 1 CARTON (64693-002-01) > 353 L in 1 CYLINDER

• Marketing Start Date: 1999-12-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64693-002-01 [64693000201]

INOmax GAS

• Marketing Category: NDA
• Application Number: NDA020845
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-12-23

NDC 64693-002-02 [64693000202]

INOmax GAS

• Marketing Category: NDA
• Application Number: NDA020845
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-12-23

Drug Details

Active Ingredients

Ingredient	Strength
NITRIC OXIDE	.98 mg/L

OpenFDA Data

• SPL SET ID: 762b51be-1893-4cd1-9511-e645fc420d3a
• Manufacturer:
  • INO Therapeutics
• UNII:
  • 31C4KY9ESH
• RxNorm Concept Unique ID - RxCUI:
  • 582608
  • 827693
• UPC Code:
  • 0364693002025

Pharmacological Class

• Vasodilation [PE]
• Vasodilator [EPC]
• Vasodilation [PE]
• Vasodilator [EPC]

NDC Crossover Matching brand name "INOmax" or generic name "Nitric Oxide"

NDC	Brand Name	Generic Name
64693-002	INOmax	nitric oxide
72385-001	GENOSYL	nitric oxide
72385-002	GENOSYL	nitric oxide
80519-301	NOW st	NITRIC OXIDE