NDC 82619-103 Esterified Estrogens And Methytestesterone

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
82619-103
Proprietary Name:
Esterified Estrogens And Methytestesterone
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
82619
Start Marketing Date: [9]
01-01-2023
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
GREEN (C48329 - DARK GREEN)
Shape:
OVAL (C48345)
Size(s):
15 MM
Imprint(s):
829
Score:
1

Code Structure Chart

Product Details

What is NDC 82619-103?

The NDC code 82619-103 is assigned by the FDA to the product Esterified Estrogens And Methytestesterone which is product labeled by Creekwood Pharmaceuticals Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 82619-103-01 100 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Esterified Estrogens And Methytestesterone?

Esterified Estrogens and Methyltestosterone Tablets and Esterified Estrogens and Methyltestosterone Tablets H.S. are indicated in the:Treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.)Esterified Estrogens and Methyltestosterone Tablets and Esterified Estrogens and Methyltestosterone Tablets H.S. have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus.

Which are Esterified Estrogens And Methytestesterone UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Esterified Estrogens And Methytestesterone?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 197670 - estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral Tablet
  • RxCUI: 197670 - estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet
  • RxCUI: 197670 - EEMT DS Oral Tablet
  • RxCUI: 238006 - estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral Tablet
  • RxCUI: 238006 - estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral Tablet

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".