NDC 51862-148 Haloette

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:
51862-148
Proprietary Name:
Haloette
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Mayne Pharma Inc.
Labeler Code:
51862
Start Marketing Date: [9]
12-01-2022
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 51862-148-03

Package Description: 3 POUCH in 1 CARTON / 21 d in 1 POUCH (51862-148-01)

Price per Unit: $64.60212 per EA

Product Details

What is NDC 51862-148?

The NDC code 51862-148 is assigned by the FDA to the product Haloette which is product labeled by Mayne Pharma Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 51862-148-03 3 pouch in 1 carton / 21 d in 1 pouch (51862-148-01). 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 Haloette?

FOR VAGINAL USE ONLYHaloette® is indicated for use by females of reproductive age to prevent pregnancy.

Which are Haloette UNII Codes?

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

Which are Haloette Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

  • ETHYLENE-VINYL ACETATE COPOLYMER (28% VINYL ACETATE) (UNII: 8ILA5X28VS)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • ETHYLENE-VINYL ACETATE COPOLYMER (9% VINYLACETATE) (UNII: 4OKC630HS6)

What is the NDC to RxNorm Crosswalk for Haloette?

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: 1367436 - etonogestrel 0.12 MG / ethinyl estradiol 0.015 MG per 24HR 3 Week Vaginal System
  • RxCUI: 1367436 - 21 DAY ethinyl estradiol 0.000625 MG/HR / etonogestrel 0.005 MG/HR Vaginal System
  • RxCUI: 1367436 - ethinyl estradiol 0.015 MG / etonogestrel 0.12 MG per 24HR 3 Week Vaginal System
  • RxCUI: 1367436 - ethinyl estradiol 15 MCG / etonogestrel 120 MCG per 24HR 3 Week Vaginal System
  • RxCUI: 2622921 - HALOETTE 0.12 MG / 0.015 MG per 24HR 3 Week Vaginal System

* Please review the disclaimer below.

Patient Education

Estrogen and Progestin (Vaginal Ring Contraceptives)


Estrogen and progestin vaginal ring contraceptives are used to prevent pregnancy. Estrogen (ethinyl estradiol) and progestin (etonogestrel or segesterone) are two female sex hormones. Estrogen and progestin are in a class of medications called combination hormonal contraceptives (birth control medications). Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering. Contraceptive vaginal rings are a very effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
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* 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".