Infants Silapap
NDC Package 21695-887-15

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Infants Silapap is ■ this product does not contain directions or complete warnings for adult use■ do not give more than directed (see overdose warning)■ find right dose on chart, if possible use weight to dose; otherwise, use age■ use only enclosed dropper designed for use with this product, do not use any other dosing device■ fill to dose level■ dispense liquid slowly into child's mouth, toward inner cheek■ may be given alone or mixed with formula, milk, juice etc.■ If needed, repeat dose every 4 hours■ do not give more than 5 times in 24 hours■ Replace dropper tightly to maintain child resistanceWeight (lb)Age (yr)Dose (mL)under 24under 2 yearsask a doctor24-352-3 years 1.6 mL (0.8 + 0.8 mL)For accurate dosing follow dosing instructions using the enclosed dropper. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-887 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
21695-887-15
Package Description
15 mL in 1 BOTTLE, DROPPER
Product Code
21695-887
11-Digit Billing Format
21695088715
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
15 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Infants Silapap
Dosage Form
-
Usage Information
■ this product does not contain directions or complete warnings for adult use■ do not give more than directed (see overdose warning)■ find right dose on chart, if possible use weight to dose; otherwise, use age■ use only enclosed dropper designed for use with this product, do not use any other dosing device■ fill to dose level■ dispense liquid slowly into child's mouth, toward inner cheek■ may be given alone or mixed with formula, milk, juice etc.■ If needed, repeat dose every 4 hours■ do not give more than 5 times in 24 hours■ Replace dropper tightly to maintain child resistanceWeight (lb)Age (yr)Dose (mL)under 24under 2 yearsask a doctor24-352-3 years 1.6 mL (0.8 + 0.8 mL)For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb. Other information Store between 20° - 25°C (68° - 77°F)

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
part343
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
04-01-1997
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (21695-887). Click a package code to view its specific billing and regulatory data.

21695-887-30
30 mL in 1 BOTTLE, DROPPER

* 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 21695-887-15 identifies a specific commercial package of 15 ml in 1 bottle, dropper of Infants Silapap, labeled by Rebel Distributors Corp. This product is billed per "ML" milliliter and contains an estimated amount of 15 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rebel Distributors Corp on April 01, 1997. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695088715. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 15 total billable units per package. 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)
21695-887-15
11-Digit CMS (5-4-2)
21695-0887-15

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