NDC 64950-359

GOPRELTO

Cocaine Hydrochloride

GOPRELTO is a Nasal Solution in the Human Prescription Drug category. It is labeled and distributed by Genus Lifesciences Inc.. The primary component is Cocaine Hydrochloride.

• Product ID: 64950-359_5e9b766e-0035-4018-b6f7-868571de6af0
• NDC: 64950-359
• Product Type: Human Prescription Drug
• Proprietary Name: GOPRELTO
• Generic Name: Cocaine Hydrochloride
• Dosage Form: Solution
• Route of Administration: NASAL
• Marketing Start Date: 2018-01-08
• Marketing Category: NDA / NDA
• Application Number: NDA209963
• Labeler Name: Genus Lifesciences Inc.
• Substance Name: COCAINE HYDROCHLORIDE
• Active Ingredient Strength: 40 mg/mL
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 64950-359-04

1 BOTTLE, GLASS in 1 CARTON (64950-359-04) > 4 mL in 1 BOTTLE, GLASS

• Marketing Start Date: 2018-01-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64950-359-04 [64950035904]

GOPRELTO SOLUTION

• Marketing Category: NDA
• Application Number: NDA209963
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-01-08

Drug Details

Active Ingredients

Ingredient	Strength
COCAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: 689750b7-8e51-47d9-a428-078f3f6c9dec
• Manufacturer:
  • Genus Lifesciences Inc.
• UNII:
  • XH8T8T6WZH
• RxNorm Concept Unique ID - RxCUI:
  • 1995293
  • 1995288
• UPC Code:
  • 0364950359046

NDC Crossover Matching brand name "GOPRELTO" or generic name "Cocaine Hydrochloride"

NDC	Brand Name	Generic Name
64950-359	GOPRELTO	cocaine hydrochloride
0527-1728	Cocaine Hydrochloride	Cocaine Hydrochloride
0527-1729	Cocaine Hydrochloride	Cocaine Hydrochloride
64950-362	cocaine hydrochloride	cocaine hydrochloride