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  5. NDC Package Code: 35573-470-30 Milophene

NDC Package 35573-470-30 Milophene

Clomiphene Citrate Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
35573-470-30
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
35573-470
Proprietary Name:
Milophene
Non-Proprietary Name:
Clomiphene Citrate
Substance Name:
Clomiphene Citrate
Usage Information:
This medication is used to treat infertility in women. It works by stimulating an increase in the amount of hormones that support the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary pituitary or ovarian failure).
11-Digit NDC Billing Format:
35573047030
Product Type:
Human Prescription Drug
Labeler Name:
Burel Pharmaceuticals, Llc
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
CLOMIPHENE CITRATE 50 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA072196
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-15-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 35573-470-30?

The NDC Packaged Code 35573-470-30 is assigned to a package of 30 tablet in 1 bottle of Milophene, a human prescription drug labeled by Burel Pharmaceuticals, Llc. The product's dosage form is tablet and is administered via oral form.

Is NDC 35573-470 included in the NDC Directory?

Yes, Milophene with product code 35573-470 is active and included in the NDC Directory. The product was first marketed by Burel Pharmaceuticals, Llc on August 15, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 35573-470-30?

The 11-digit format is 35573047030. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-235573-470-305-4-235573-0470-30