Hydrocortisone And Acetic Acid Solution
NDC Package 71656-064-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hydrocortisone And Acetic Acid (hydrocortisone and acetic acid otic) solution is classified as a

administered via auricular (otic) route. This formulation utilizes a solution delivery system. Marketed by Saptalis Pharmaceuticals, Llc, this product is identified by NDC 71656-064 and is authorized under FDA application NDA012770.

Identification & Billing

NDC Package Code
71656-064-10
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code
71656-064
11-Digit Billing Format
71656006410
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 313786 - acetic acid 2 % / hydrocortisone 1 % Otic Solution
  • RxCUI: 313786 - acetic acid 20 MG/ML / hydrocortisone 10 MG/ML Otic Solution

Clinical Specifications

Proprietary Name
Hydrocortisone And Acetic Acid
Non-Proprietary Name
Hydrocortisone And Acetic Acid Otic
Substance Name
Acetic Acid; Hydrocortisone
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Saptalis Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA012770
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
02-23-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71656-064-10 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Hydrocortisone And Acetic Acid, a human prescription drug labeled by Saptalis Pharmaceuticals, Llc. This solution is formulated for auricular (otic) use and contains acetic acid; hydrocortisone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Saptalis Pharmaceuticals, Llc on February 23, 2024. The current certification is valid through December 31, 2026.

How is this Saptalis Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71656006410. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
71656-064-10
11-Digit CMS (5-4-2)
71656-0064-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.