Foster And Thrive Miconazole Cream
NDC Package 70677-1222-1

11-digit billing NDC: 70677122201 · Billing unit: GM · 45 GM per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Foster And Thrive Miconazole (miconazole nitrate) cream is •before using this product read the enclosed consumer information leaflet for complete directions and information•adults and children 12 years of age and over:•applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. This formulation utilizes a cream delivery system. Marketed by Strategic Sourcing Services Llc, this product is identified by NDC 70677-1222 and is authorized under FDA application ANDA074760.

Identification & Billing

NDC Package Code
70677-1222-1
Package Description
1 TUBE, WITH APPLICATOR in 1 CARTON / 45 g in 1 TUBE, WITH APPLICATOR
Product Code
70677-1222
11-Digit Billing Format
70677122201
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Foster And Thrive Miconazole
Non-Proprietary Name
Miconazole Nitrate
Substance Name
Miconazole Nitrate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
MICONAZOLE NITRATE 2 g/100g
Pharmacologic Class
Usage Information
•before using this product read the enclosed consumer information leaflet for complete directions and information•adults and children 12 years of age and over:•applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.•use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. 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
Strategic Sourcing Services Llc
Product Type
Human Otc Drug
FDA Application #
ANDA074760
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-25-2023
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 70677-1222-1 identifies a specific commercial package of 1 tube, with applicator in 1 carton / 45 g in 1 tube, with applicator of Foster And Thrive Miconazole, a human over the counter drug labeled by Strategic Sourcing Services Llc. This cream 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 October 25, 2023. 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: 70677122201. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 45 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 (5-4-1)
70677-1222-1
11-Digit CMS (5-4-2)
70677-1222-01

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