NDC Compounded Drug 69761-327-51 Progesterone

Gel Topical

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Progesterone 125 Mg/g
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 69761-327
NDC Package Code 69761-327-51
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 69761032751
Package Description 30 GEL in 1 BOTTLE, PUMP
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		 Human Compounded Drug
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 Progesterone 125 Mg/g
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		 Progesterone 125 Mg/g
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		 Progesterone
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.		 Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (e.g., fibroids, cancer of the uterus). Progesterone must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.
Dosage Form Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Route Name Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 69761
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Qualgen Llc
Substance Name Progesterone
Active Ingredients Information 125 mg
Reporting Period 2022-2

NDC Crossover Products Matching Progesterone

NDC crossover of Progesterone 125 Mg/g with NDC 69761-327 a human compounded drug with other similar products matching the same substance name (Progesterone) and the same administration route (topical) or dosage form (gel).

Frequently Asked Questions

What is the NDC number assigned to Progesterone 50 Mg/g?

Progesterone 50 Mg/g was assigned by its manufacturer with NDC product code 69761-327. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Progesterone 50 Mg/g?

The NDC package code 69761-327-51 was assigned to a 30 GEL in 1 BOTTLE, PUMP of progesterone administered topical via gel.

Who manufactures this product?

Progesterone 50 Mg/g is manufactured by an outsourced facility and labeled by Qualgen Llc. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.

Which are the NDC crossover matchings for this product?

We found 1 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Qualgen LLC with NDC product codes 69761-357-51.