NDC 17856-0120

CaroSpir

Carospir

CaroSpir is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corp.. The primary component is Spironolactone.

• Product ID: 17856-0120_16683cbd-f833-40d0-ae1b-6526c06f6276
• NDC: 17856-0120
• Product Type: Human Prescription Drug
• Proprietary Name: CaroSpir
• Generic Name: Carospir
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-22
• Marketing Category: NDA / NDA
• Application Number: NDA209478
• Labeler Name: ATLANTIC BIOLOGICALS CORP.
• Substance Name: SPIRONOLACTONE
• Active Ingredient Strength: 25 mg/5mL
• Pharm Classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 17856-0120-1

72 CUP in 1 BOX (17856-0120-1) > 2.5 mL in 1 CUP (17856-0120-2)

• Marketing Start Date: 2020-05-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17856-0120-1 [17856012001]

CaroSpir SUSPENSION

• Marketing Category: NDA
• Application Number: NDA209478
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-05-20
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-05-20

Drug Details

Active Ingredients

Ingredient	Strength
SPIRONOLACTONE	25 mg/5mL

OpenFDA Data

• SPL SET ID: 07504afc-f0b6-40f6-8719-cd1c3e67fc35
• Manufacturer:
  • ATLANTIC BIOLOGICALS CORP.
• UNII:
  • 27O7W4T232
• RxNorm Concept Unique ID - RxCUI:
  • 104232

Pharmacological Class

• 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