Miconazole 7 Suppository
NDC Package 49348-833-61

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

Package Information

Miconazole 7 (miconazole nitrate) suppositories is a medication used to treat vaginal yeast infections. This formulation utilizes a suppository delivery system. Marketed by Strategic Sourcing Services Llc, this product is identified by NDC 49348-833 and is authorized under FDA application ANDA073507.

Identification & Billing

NDC Package Code
49348-833-61
Package Description
7 SUPPOSITORY in 1 APPLICATOR
Product Code
49348-833
11-Digit Billing Format
49348083361
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
7 EA
RxNorm Crosswalk
RxCUI: 992780 - miconazole nitrate 100 MG Vaginal Insert

Clinical Specifications

Proprietary Name
Miconazole 7
Non-Proprietary Name
Miconazole Nitrate
Substance Name
Miconazole Nitrate
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
MICONAZOLE NITRATE 100 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

Regulatory & Marketing

Labeler Name
Strategic Sourcing Services Llc
Product Type
Human Otc Drug
FDA Application #
ANDA073507
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-09-2011
End Marketing Date
12-09-2026
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 49348-833-61 identifies a specific commercial package of 7 suppository in 1 applicator of Miconazole 7, a human over the counter drug labeled by Strategic Sourcing Services Llc. This suppository is formulated for vaginal use and contains miconazole nitrate 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 December 09, 2011.

What are the primary indications for this medication?

This medication is used to treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

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: 49348083361. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 7 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)
49348-833-61
11-Digit CMS (5-4-2)
49348-0833-61

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