NDC 46287-020

CaroSpir

Carospir

CaroSpir is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Cmp Pharma, Inc.. The primary component is Spironolactone.

• Product ID: 46287-020_3b12fec5-8754-4be2-a48f-58fba65f3f3c
• NDC: 46287-020
• Product Type: Human Prescription Drug
• Proprietary Name: CaroSpir
• Generic Name: Carospir
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-04
• Marketing Category: NDA / NDA
• Application Number: NDA209478
• Labeler Name: CMP Pharma, Inc.
• Substance Name: SPIRONOLACTONE
• Active Ingredient Strength: 25 mg/5mL
• Pharm Classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 46287-020-01

473 mL in 1 BOTTLE (46287-020-01)

• Marketing Start Date: 2017-08-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46287-020-04 [46287002004]

CaroSpir SUSPENSION

• Marketing Category: NDA
• Application Number: NDA209478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-08-04

NDC 46287-020-01 [46287002001]

CaroSpir SUSPENSION

• Marketing Category: NDA
• Application Number: NDA209478
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-08-04

Drug Details

Active Ingredients

Ingredient	Strength
SPIRONOLACTONE	25 mg/5mL

OpenFDA Data

• SPL SET ID: c4f70a04-7d89-4b73-8b02-17d43471bf08
• Manufacturer:
  • CMP Pharma, Inc.
• UNII:
  • 27O7W4T232
• RxNorm Concept Unique ID - RxCUI:
  • 104232
• UPC Code:
  • 0346287020011
  • 0346287020042

Pharmacological Class

• Aldosterone Antagonist [EPC]
• Aldosterone Antagonists [MoA]
• Aldosterone Antagonist [EPC]
• Aldosterone Antagonists [MoA]

NDC Crossover Matching brand name "CaroSpir" or generic name "Carospir"

NDC	Brand Name	Generic Name
17856-0120	CaroSpir	CaroSpir
46287-020	CaroSpir	CaroSpir