Sunmark Solution
NDC Package 49348-636-34

11-digit billing NDC: 49348063634 · Billing unit: ML · 120 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sunmark (loratadine) solution is adults and children 6 years and over2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hourschildren 2 to under 6 years of age1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hoursconsumers with liver or kidney diseaseask a doctor. This formulation utilizes a solution delivery system. Marketed by Strategic Sourcing Services Llc, this product is identified by NDC 49348-636 and is authorized under FDA application ANDA076805.

Identification & Billing

NDC Package Code
49348-636-34
Package Description
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
Product Code
49348-636
11-Digit Billing Format
49348063634
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sunmark Childrens Loratadine
Non-Proprietary Name
Loratadine
Substance Name
Loratadine
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LORATADINE 5 mg/5mL
Usage Information
Adults and children 6 years and over2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hourschildren 2 to under 6 years of age1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hoursconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Strategic Sourcing Services Llc
Product Type
Human Otc Drug
FDA Application #
ANDA076805
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-20-2004
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 49348-636-34 identifies a specific commercial package of 1 bottle in 1 carton / 120 ml in 1 bottle of Sunmark Childrens Loratadine, a human over the counter drug labeled by Strategic Sourcing Services Llc. This solution is formulated for oral use and contains loratadine 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 Strategic Sourcing Services Llc on August 20, 2004. The current certification is valid through December 31, 2027.

How is this Strategic Sourcing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49348063634. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 120 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)
49348-636-34
11-Digit CMS (5-4-2)
49348-0636-34

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