Prempro
NDC Package 54868-3799-0
Package Information
Prempro is this medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3799 and is authorized under FDA application NDA020527.
Identification & Billing
- RxCUI: 1000351 - estrogens, conjugated 0.3 MG / medroxyPROGESTERone acetate 1.5 MG Oral Tablet
- RxCUI: 1000351 - estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet
- RxCUI: 1000352 - estrogens, conjugated 0.45 MG / medroxyPROGESTERone acetate 1.5 MG Oral Tablet
- RxCUI: 1000352 - estrogens, conjugated (USP) 0.45 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet
- RxCUI: 1000355 - estrogens, conjugated 0.625 MG / medroxyPROGESTERone acetate 2.5 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-3799 - Prempro
- 54868-3799-0 - 1 BLISTER PACK in 1 CARTON / 28 TABLET, SUGAR COATED in 1 BLISTER PACK
- 54868-3799 - Prempro
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 54868-3799-0 identifies a specific commercial package of 1 blister pack in 1 carton / 28 tablet, sugar coated in 1 blister pack of Prempro, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Physicians Total Care, Inc. on June 20, 1996. The current certification is valid through December 31, 2017.
What are the primary indications for this medication?
This medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). 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. 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. This medication may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen/progestin treatment.
How is this Physicians Total Care, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868379900. 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 Package segment to maintain the 5-4-2 structure.