NDC 69803-100

Kovanaze

Tetracaine Hydrochloride And Oxymetazoline Hydrochloride

Kovanaze is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by St. Renatus. The primary component is Tetracaine Hydrochloride; Oxymetazoline Hydrochloride.

• Product ID: 69803-100_7aceb111-5e79-5057-e053-2991aa0a9286
• NDC: 69803-100
• Product Type: Human Prescription Drug
• Proprietary Name: Kovanaze
• Generic Name: Tetracaine Hydrochloride And Oxymetazoline Hydrochloride
• Dosage Form: Spray
• Route of Administration: NASAL
• Marketing Start Date: 2016-09-01
• Marketing Category: NDA / NDA
• Application Number: NDA208032
• Labeler Name: St. Renatus
• Substance Name: TETRACAINE HYDROCHLORIDE; OXYMETAZOLINE HYDROCHLORIDE
• Active Ingredient Strength: 30 mg/mL; mg/mL
• Pharm Classes: Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC],Vasoconstrictor [EPC],Vasoconstriction [PE],Increased Sympathetic Activity [PE],Imidazolines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69803-100-10

30 APPLICATOR in 1 CARTON (69803-100-10) > .2 mL in 1 APPLICATOR

• Marketing Start Date: 2016-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69803-100-10 [69803010010]

Kovanaze SPRAY

• Marketing Category: NDA
• Application Number: NDA208032
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-01

Drug Details

Active Ingredients

Ingredient	Strength
TETRACAINE HYDROCHLORIDE	30 mg/mL

OpenFDA Data

• SPL SET ID: d2af5404-3cfe-445d-8328-19e667ecdc43
• Manufacturer:
  • St. Renatus
• UNII:
  • K89MJ0S5VY
  • 5NF5D4OPCI
• RxNorm Concept Unique ID - RxCUI:
  • 1809050
  • 1809056

Pharmacological Class

• Esters [CS]
• Local Anesthesia [PE]
• Ester Local Anesthetic [EPC]
• Vasoconstrictor [EPC]
• Vasoconstriction [PE]
• Increased Sympathetic Activity [PE]
• Imidazolines [CS]
• Esters [CS]
• Local Anesthesia [PE]
• Ester Local Anesthetic [EPC]
• Vasoconstrictor [EPC]
• Vasoconstriction [PE]
• Increased Sympathetic Activity [PE]
• Imidazolines [CS]