Miconazole 3 Combination Pack Kit
NDC Package 49035-345-03

11-digit billing NDC: 49035034503 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Miconazole 3 Combination Pack (miconazole nitrate) kits is before using this product read the enclosed consumer information leaflet for complete directions and informationadults and children 12 years of age and over:suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Wash applicator away after use.external cream: Use cap to puncture seal. This formulation utilizes a kit delivery system. Marketed by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc), this product is identified by NDC 49035-345 and is authorized under FDA application ANDA074926.

Identification & Billing

NDC Package Code
49035-345-03
Package Description
1 KIT in 1 PACKAGE, COMBINATION * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE
Product Code
49035-345
11-Digit Billing Format
49035034503
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 992765 - miconazole nitrate 200 MG Vaginal Insert
  • RxCUI: 992766 - {1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } Pack
  • RxCUI: 992766 - miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) Pack
  • RxCUI: 992766 - miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)
  • RxCUI: 992766 - miconazole 3 Day Vaginal Insert Combination Pack

Clinical Specifications

Proprietary Name
Miconazole 3 Combination Pack
Non-Proprietary Name
Miconazole Nitrate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Before using this product read the enclosed consumer information leaflet for complete directions and informationadults and children 12 years of age and over:suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Wash applicator away after use.external cream: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc)
Product Type
Human Otc Drug
FDA Application #
ANDA074926
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2020
End Marketing Date
12-31-2026
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 49035-345-03 identifies a specific commercial package of 1 kit in 1 package, combination * 3 suppository in 1 blister pack * 9 g in 1 tube of Miconazole 3 Combination Pack, a human over the counter drug labeled by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc). This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This kit is formulated for use and contains 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 Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) on May 01, 2020.

How is this Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49035034503. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
49035-345-03
11-Digit CMS (5-4-2)
49035-0345-03

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