NDC 0095-0201

VoSoL HC

Hydrocortisone And Acetic Acid

VoSoL HC is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Ecr Pharmaceuticals Co., Inc.. The primary component is Acetic Acid; Hydrocortisone.

• Product ID: 0095-0201_1c6c2a83-33de-4992-8091-33d54c1bd0c6
• NDC: 0095-0201
• Product Type: Human Prescription Drug
• Proprietary Name: VoSoL HC
• Generic Name: Hydrocortisone And Acetic Acid
• Dosage Form: Solution
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 2009-06-22
• Marketing Category: NDA / NDA
• Application Number: NDA012770
• Labeler Name: ECR Pharmaceuticals Co., Inc.
• Substance Name: ACETIC ACID; HYDROCORTISONE
• Active Ingredient Strength: 21 mg/mL; mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0095-0201-10

1 BOTTLE, DROPPER in 1 CARTON (0095-0201-10) > 10 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2009-06-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0095-0201-10 [00095020110]

VoSoL HC SOLUTION

• Marketing Category: NDA
• Application Number: NDA012770
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-06-22
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETIC ACID	20.75 mg/mL

OpenFDA Data

• SPL SET ID: 1c6c2a83-33de-4992-8091-33d54c1bd0c6
• Manufacturer:
  • ECR Pharmaceuticals Co., Inc.
• UNII:
  • Q40Q9N063P
  • WI4X0X7BPJ

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "VoSoL HC" or generic name "Hydrocortisone And Acetic Acid"

NDC	Brand Name	Generic Name
0095-0201	VoSoL HC	hydrocortisone and acetic acid
50383-901	hydrocortisone and acetic acid	hydrocortisone and acetic acid
51672-3007	Hydrocortisone and Acetic Acid	Hydrocortisone and Acetic Acid