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NDC 50383-0889-15 Acetic Acid 20.65 mg/mL Details
Acetic Acid 20.65 mg/mL
Acetic Acid is a AURICULAR (OTIC) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Akorn. The primary component is ACETIC ACID.
Product Information
| NDC | 50383-0889 |
|---|---|
| Product ID | 50383-889_975ebc3f-2649-42c7-8f06-3551b94c5a7e |
| Associated GPIs | 87400010102010 |
| GCN Sequence Number | 008101 |
| GCN Sequence Number Description | acetic acid SOLUTION 2 % OTIC (EAR) |
| HIC3 | Q8B |
| HIC3 Description | EAR PREPARATIONS, MISC. ANTI-INFECTIVES |
| GCN | 34341 |
| HICL Sequence Number | 003597 |
| HICL Sequence Number Description | ACETIC ACID |
| Brand/Generic | Generic |
| Proprietary Name | Acetic Acid |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetic Acid |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | AURICULAR (OTIC) |
| Active Ingredient Strength | 20.65 |
| Active Ingredient Units | mg/mL |
| Substance Name | ACETIC ACID |
| Labeler Name | Akorn |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA012179 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 50383-0889-15 (50383088915)
| NDC Package Code | 50383-889-15 |
|---|---|
| Billing NDC | 50383088915 |
| Package | 1 BOTTLE in 1 BOX (50383-889-15) / 15 mL in 1 BOTTLE |
| Marketing Start Date | 2010-01-22 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.58324 |
| Pricing Unit | ML |
| Effective Date | 2022-11-23 |
| NDC Description | ACETIC ACID 2% EAR SOLUTION |
| 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 c53fc11e-b177-446e-839d-391e1b2eacff Details
DESCRIPTION
Acetic Acid Otic Solution, USP is a solution of acetic acid (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), and sodium acetate (0.015%). The empirical formula for acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:
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
PEDIATRIC USE
ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
Carefully remove all cerumen and debris to allow acetic acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with 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 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 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
INGREDIENTS AND APPEARANCE
| ACETIC ACID
acetic acid solution |
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| Labeler - Akorn (117696873) |
| Registrant - Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | MANUFACTURE(50383-889) | |