Combipatch
NDC Package 0078-0378-45
Package Information
Combipatch is this medication contains 2 female hormones: an estrogen (estradiol) and a progestin (norethindrone). Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0378 and is authorized under FDA application NDA020870.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0078 - Novartis Pharmaceuticals Corporation
- 0078-0378 - Combipatch
- 0078-0378-45 - 24 POUCH in 1 CARTON / 3.5 d in 1 POUCH
- 0078-0378 - Combipatch
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.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (0078-0378). Click a package code to view its specific billing and regulatory data.
* 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 0078-0378-45 identifies a specific commercial package of 24 pouch in 1 carton / 3.5 d in 1 pouch of Combipatch, labeled by Novartis Pharmaceuticals Corporation. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on January 01, 2000. The current certification is valid through April 30, 2016.
What are the primary indications for this medication?
This medication contains 2 female hormones: an estrogen (estradiol) and a progestin (norethindrone). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. The progestin in this medication helps to reduce the risk of cancer of the uterus which can be caused by using estrogen. Women who have had their uterus removed do not need the progestin and therefore should not use this combination medication. This medication may also be used by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure). If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected.
How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078037845. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.