Natroba Suspension
NDC Package 84635-929-04

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

Package Information

Natroba (spinosad) suspension is a medication used to treat head lice, tiny insects that infest and irritate your scalp. This formulation utilizes a suspension delivery system. Marketed by Cipher Pharmaceuticals Inc., this product is identified by NDC 84635-929 and is authorized under FDA application NDA022408.

Identification & Billing

NDC Package Code
84635-929-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC
Product Code
84635-929
11-Digit Billing Format
84635092904
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Natroba
Non-Proprietary Name
Spinosad
Substance Name
Spinosad
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
SPINOSAD 9 mg/mL
Pharmacologic Class
Pediculicide - [EPC] (Established Pharmacologic Class)
Usage Information
This medication is used to treat head lice, tiny insects that infest and irritate your scalp. Head lice lay small white eggs (nits) at the roots of hair close to the scalp, especially on the hairline at the back of the neck and behind the ears. Spinosad works by paralyzing and killing lice and their eggs. This medication should not be used on infants younger than 6 months due to the increased risk for serious side effects.

Regulatory & Marketing

Labeler Name
Cipher Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022408
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-25-2011
Listing Expiration
12-31-2027
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 84635-929-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 120 ml in 1 bottle, plastic of Natroba, a human prescription drug labeled by Cipher Pharmaceuticals Inc.. This suspension is formulated for topical use and contains spinosad 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 Cipher Pharmaceuticals Inc. on January 25, 2011. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat head lice, tiny insects that infest and irritate your scalp. Head lice lay small white eggs (nits) at the roots of hair close to the scalp, especially on the hairline at the back of the neck and behind the ears. Spinosad works by paralyzing and killing lice and their eggs. This medication should not be used on infants younger than 6 months due to the increased risk for serious side effects.

How is this Cipher Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84635092904. 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)
84635-929-04
11-Digit CMS (5-4-2)
84635-0929-04

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