NDC 50383-901

hydrocortisone and acetic acid

Hydrocortisone And Acetic Acid

hydrocortisone and acetic acid is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Acetic Acid; Hydrocortisone.

• Product ID: 50383-901_0ad314b3-4aaa-4c5f-8d26-9949c780d9e8
• NDC: 50383-901
• Product Type: Human Prescription Drug
• Proprietary Name: hydrocortisone and acetic acid
• Generic Name: Hydrocortisone And Acetic Acid
• Dosage Form: Solution
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 2009-06-04
• Marketing Category: NDA / NDA
• Application Number: NDA012770
• Labeler Name: Hi-Tech Pharmacal 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: 2021-12-31

Packaging

NDC 50383-901-10

1 BOTTLE, DROPPER in 1 CARTON (50383-901-10) > 10 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2009-06-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50383-901-10 [50383090110]

hydrocortisone and acetic acid SOLUTION

• Marketing Category: NDA
• Application Number: NDA012770
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-06-04

Drug Details

Active Ingredients

Ingredient	Strength
ACETIC ACID	20.75 mg/mL

OpenFDA Data

• SPL SET ID: ffd1edc1-2f40-4b0a-a53a-9fb53b8d3184
• Manufacturer:
  • Hi-Tech Pharmacal Co., Inc.
• UNII:
  • Q40Q9N063P
  • WI4X0X7BPJ
• RxNorm Concept Unique ID - RxCUI:
  • 313786

Pharmacological Class

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

Medicade Reported Pricing

50383090110 HYDROCORTISON-ACETIC ACID SOLN

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "hydrocortisone and acetic acid" or generic name "Hydrocortisone And Acetic Acid"

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