NDC 0527-1961

NUMBRINO

Cocaine Hydrochloride Nasal

NUMBRINO is a Nasal Solution in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Cocaine Hydrochloride.

• Product ID: 0527-1961_00694a20-4c22-43cf-ab6c-17cb1d0b26a4
• NDC: 0527-1961
• Product Type: Human Prescription Drug
• Proprietary Name: NUMBRINO
• Generic Name: Cocaine Hydrochloride Nasal
• Dosage Form: Solution
• Route of Administration: NASAL
• Marketing Start Date: 2020-01-10
• Marketing Category: NDA / NDA
• Application Number: NDA209575
• Labeler Name: Lannett Company, Inc.
• Substance Name: COCAINE HYDROCHLORIDE
• Active Ingredient Strength: 40 mg/mL
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0527-1961-73

1 BOTTLE, GLASS in 1 CARTON (0527-1961-73) > 10 mL in 1 BOTTLE, GLASS

• Marketing Start Date: 2020-01-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0527-1961-73 [00527196173]

NUMBRINO SOLUTION

• Marketing Category: NDA
• Application Number: NDA209575
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-01-10

NDC 0527-1961-74 [00527196174]

NUMBRINO SOLUTION

• Marketing Category: NDA
• Application Number: NDA209575
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-01-10

Drug Details

Active Ingredients

Ingredient	Strength
COCAINE HYDROCHLORIDE	40 mg/mL

OpenFDA Data

• SPL SET ID: 94f9b3f8-bce5-41ed-9453-c54ed1d6c269
• Manufacturer:
  • Lannett Company, Inc.
• UNII:
  • XH8T8T6WZH
• RxNorm Concept Unique ID - RxCUI:
  • 2272608
  • 1995288

NDC Crossover Matching brand name "NUMBRINO" or generic name "Cocaine Hydrochloride Nasal"

NDC	Brand Name	Generic Name
0527-1961	NUMBRINO	cocaine hydrochloride nasal
0527-1971	cocaine hydrochloride nasal	cocaine hydrochloride nasal