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NDC 64980-0424-15 Acetic Acid 20 mg/mL Details

Acetic Acid 20 mg/mL

Acetic Acid is a AURICULAR (OTIC) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is ACETIC ACID.

Product Information

NDC	64980-0424
Product ID	64980-424_0cd0c810-ae92-4738-a194-ea707a8cde32
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
Active Ingredient Units	mg/mL
Substance Name	ACETIC ACID
Labeler Name	Rising Pharmaceuticals, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207280
Listing Certified Through	n/a

Package

Package Images

NDC 64980-0424-15 (64980042415)

Pricing Information
NDC Package Code	64980-424-15
Billing NDC	64980042415
Package	1 BOTTLE in 1 CARTON (64980-424-15) / 15 mL in 1 BOTTLE
Marketing Start Date	2018-03-14
NDC Exclude Flag	N
Price Per Unit	1.32893
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	ACETIC ACID 2% EAR SOLUTION
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 1266c51d-2616-43c5-943a-727df5a7e9d4 Details

DESCRIPTION

Acetic Acid Otic Solution USP is a nonaqueous solution of glacial acetic acid, USP (2%), in a propylene glycol vehicle containing benzethonium chloride, USP (0.02%); propylene glycol diacetate, NF (3%) and sodium acetate, USP (0.015%). It may also contain citric acid, USP.

The molecular formula for acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:

Acetic Acid Otic Solution is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

CLINICAL PHARMACOLOGY

Acetic acid is anti-bacterial and anti-fungal; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.

INDICATIONS AND USAGE

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

CONTRAINDICATIONS

Hypersensitivity to Acetic Acid Otic Solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

WARNINGS

Discontinue promptly if sensitization or irritation occurs.

PRECAUTIONS

Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.

PEDIATRIC USE

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

ADVERSE REACTIONS

Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

DOSAGE AND ADMINISTRATION

Carefully remove all cerumen and debris to allow Acetic Acid Otic Solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the solution 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 the solution 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 Otic Solution 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

Acetic Acid Otic Solution USP, 2% is available in 15 mL (NDC 64980-424-15) measured-drop, safety- tip plastic bottles.

STORAGE

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

KEEP CONTAINER TIGHTLY CLOSED

Rx Only

Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

Rev. 05/2018

MADE IN USA

Rev. 12/2018

PRINCIPAL DISPLAY PANEL - 15 mL bottle

Rising®

NDC 64980-424-15

Acetic Acid Otic

Solution USP, 2%

DO NOT USE IF BAND PRINTED

"SEALED FOR YOUR PROTECTION”

AROUND CAP IS BROKEN OR MISSING.

15 mL

Rx only

PRINCIPAL DISPLAY PANEL - 15 mL Carton

Rising®

NDC 64980-424-15

Acetic Acid

Otic Solution

USP, 2%

DO NOT USE IF BAND

PRINTED "SEALED FOR

YOUR PROTECTION"

AROUND CAP IS BROKEN

OR MISSING"

15mL

Rx only

INGREDIENTS AND APPEARANCE

ACETIC ACID

acetic acid solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64980-424
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)	ACETIC ACID	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
SODIUM ACETATE (UNII: 4550K0SC9B)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64980-424-15	1 in 1 CARTON	03/14/2018	10/30/2023
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207280	03/14/2018	10/30/2023

Labeler - Rising Pharmaceuticals, Inc. (041241766)

Revised: 7/2022

Document Id: 0cd0c810-ae92-4738-a194-ea707a8cde32

Set id: 1266c51d-2616-43c5-943a-727df5a7e9d4

Version: 6

Effective Time: 20220708