NDC Package 84415-010-01 Aluminum Hydroxide, Magnesium Hydroxide And Simethicone

Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

84415-010-01

Package Description:

100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 30 mL in 1 CUP, UNIT-DOSE

Product Code:

84415-010

Proprietary Name:

Aluminum Hydroxide, Magnesium Hydroxide And Simethicone

Non-Proprietary Name:

Aluminum Hydroxide, Magnesium Hydroxide, And Simethicone

Substance Name:

Aluminum Hydroxide; Dimethicone; Magnesium Hydroxide

Usage Information:

1,200-1,200-120 mg/30 mL• Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks agedoseAdults and children over 12 years of ageTake 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour periodChildren under 12 years of ageAsk a doctor 2,400-2,400-240 mg/30 mL• Do not use more than 2 unit dose (60 mL) in a 24 hour period or use the maximum dose for more than 2 weeks agedoseAdults and children over 12 years of ageTake 30 mL, one unit dose, one to two times daily or as directed by a doctor. Do not exceed 2 x 30 mL unit dose (60 mL) in a 24 hour periodChildren under 12 years of ageAsk a doctor

11-Digit NDC Billing Format:

84415001001

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 237870 - aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral Suspension
RxCUI: 237870 - aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral Suspension
RxCUI: 237870 - aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral Suspension
RxCUI: 237870 - aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral Suspension
RxCUI: 237870 - aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral Suspension

Product Type:

Human Otc Drug

Labeler Name:

Everpharm Llc

Dosage Form:

Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

M001.15

Marketing Category:

OTC MONOGRAPH DRUG -

Start Marketing Date:

01-16-2025

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

84415 - Everpharm Llc
- 84415-010 - Aluminum Hydroxide, Magnesium Hydroxide And Simethicone
  - 84415-010-01 - 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 30 mL in 1 CUP, UNIT-DOSE

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 disclaimer below.

Frequently Asked Questions

What is NDC 84415-010-01?

The NDC Packaged Code 84415-010-01 is assigned to a package of 100 cup, unit-dose in 1 box, unit-dose / 30 ml in 1 cup, unit-dose of Aluminum Hydroxide, Magnesium Hydroxide And Simethicone, a human over the counter drug labeled by Everpharm Llc. The product's dosage form is suspension and is administered via oral form.

Is NDC 84415-010 included in the NDC Directory?

Yes, Aluminum Hydroxide, Magnesium Hydroxide And Simethicone with product code 84415-010 is active and included in the NDC Directory. The product was first marketed by Everpharm Llc on January 16, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 84415-010-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 84415-010-01?

The 11-digit format is 84415001001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	84415-010-01	5-4-2	84415-0010-01

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