Loestrin
NDC Package 51285-129-98
Package Information
Loestrin is this combination hormone medication is used to prevent pregnancy. Marketed by Teva Women's Health, Inc., this product is identified by NDC 51285-129 and is authorized under FDA application ANDA076064.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 51285 - Teva Women's Health, Inc.
- 51285-129 - Loestrin
- 51285-129-98 - 30 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
- 51285-129 - Loestrin
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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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 51285-129-98 identifies a specific commercial package of 30 pouch in 1 carton / 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Loestrin Fe 28 Day, labeled by Teva Women's Health, Inc.. 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 Teva Women's Health, Inc. on July 29, 2015. The current certification is valid through September 20, 2022.
What are the primary indications for this medication?
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin and an estrogen. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
How is this Teva Women's Health, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 51285012998. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 Product segment to maintain the 5-4-2 structure.