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NDC 50383-0901-10 hydrocortisone and acetic acid 20.75; 10.375 mg/mL; mg/mL Details
hydrocortisone and acetic acid 20.75; 10.375 mg/mL; mg/mL
hydrocortisone and acetic acid is a AURICULAR (OTIC) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Akorn Operating Company LLC. The primary component is ACETIC ACID; HYDROCORTISONE.
Product Information
NDC | 50383-0901 |
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Product ID | 50383-901_9b68befb-ac5a-4db8-a8cf-24a89bbf3155 |
Associated GPIs | 87300020102000 |
GCN Sequence Number | 048554 |
GCN Sequence Number Description | hydrocortisone/acetic acid DROPS 1 %-2 % OTIC (EAR) |
HIC3 | Q8B |
HIC3 Description | EAR PREPARATIONS, MISC. ANTI-INFECTIVES |
GCN | 14017 |
HICL Sequence Number | 003594 |
HICL Sequence Number Description | HYDROCORTISONE/ACETIC ACID |
Brand/Generic | Generic |
Proprietary Name | hydrocortisone and acetic acid |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | hydrocortisone and acetic acid |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | SOLUTION |
Route | AURICULAR (OTIC) |
Active Ingredient Strength | 20.75; 10.375 |
Active Ingredient Units | mg/mL; mg/mL |
Substance Name | ACETIC ACID; HYDROCORTISONE |
Labeler Name | Akorn Operating Company LLC |
Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA012770 |
Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 50383-0901-10 (50383090110)
NDC Package Code | 50383-901-10 |
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Billing NDC | 50383090110 |
Package | 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 |
Pricing Information | |
Price Per Unit | 6.32688 |
Pricing Unit | ML |
Effective Date | 2022-11-23 |
NDC Description | HYDROCORTISON-ACETIC ACID SOLN |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1, 5, 6 |
Classification for Rate Setting | G |
As of Date | 2022-11-23 |
Standard Product Labeling (SPL)/Prescribing Information SPL ffd1edc1-2f40-4b0a-a53a-9fb53b8d3184 Details
DESCRIPTION
Hydrocortisone and Acetic Acid Otic Solution, USP is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.05%), propylene glycol diacetate (3%) and sodium acetate (0.015%). The empirical formulas for acetic acid and hydrocortisone are CH3COOH, and C21H30O5, with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are:
Hydrocortisone and Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
CONTRAINDICATIONS
PRECAUTIONS
ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
Carefully remove all cerumen and debris to allow Hydrocortisone and Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and Acetic Acid into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of Hydrocortisone and Acetic Acid every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Hydrocortisone and Acetic Acid 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.
HOW SUPPLIED
STORAGE
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
HYDROCORTISONE AND ACETIC ACID
hydrocortisone and acetic acid solution |
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Labeler - Akorn Operating Company LLC (117696873) |
Registrant - Akorn Operating Company LLC (117693100) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Akorn Operating Company LLC | 117696873 | MANUFACTURE(50383-901) |