NDC 65162-316 Lomedia 24 Fe

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:
65162-316
Proprietary Name:
Lomedia 24 Fe
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Amneal Pharmaceuticals Of New York, Llc
Labeler Code:
65162
Start Marketing Date: [9]
12-20-2013
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
BROWN (C48332)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
WATSON;630
WATSON;075
Score:
1

Product Packages

NDC Code 65162-316-84

Package Description: 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (65162-316-58)

Price per Unit: $1.04199 per EA

Product Details

What is NDC 65162-316?

The NDC code 65162-316 is assigned by the FDA to the product Lomedia 24 Fe which is product labeled by Amneal Pharmaceuticals Of New York, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 65162-316-84 3 blister pack in 1 carton / 1 kit in 1 blister pack (65162-316-58). 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 Lomedia 24 Fe?

Lomedia 24 Fe tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Oral contraceptives are highly effective. Table 2 lists the typical unplanned pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant®* system, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE 2Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States.   % of Women Experiencing an UnintendedPregnancy within the First Year of Use% of WomenContinuing Use at OneYear3 Method(1)Typical Use1(2)Perfect Use2(3)(4)Chance4 85 85 Spermicides5 26 6 40Periodic abstinence 25  63Calendar  9 Ovulation Method  3 Sympto-Thermal6  2 Post-Ovulation  1 Cap7   Parous Women 40 26 42Nulliparous Women 20 9 56Sponge   Parous Women 40 20 42Nulliparous Women 20 9 56Diaphragm7 20 6 56Withdrawal 19 4 Condom8   Female (reality) 21 5 56Male 14 361Pill 5   71Progestin Only  0.5 Combined  0.1 IUD   Progesterone T 2.0 1.5 81Copper T 380A  0.8 0.6 78LNg 20 0.1 0.1 81Depo-Provera®* 0.3 0.3 70Norplant®* and Norplant®*2 0.05 0.05 88Female Sterilization 0.5 0.5100Male Sterilization 0.15 0.10  100Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces risk of pregnancy by at least 75%9Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.Source: Trussell J, Stewart F, Contraceptive Efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.1  Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason2  Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason3  Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year4  The percentage of women becoming pregnant noted in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% became pregnant in one year. This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandon contraception altogether5  Foams, creams, gels, vaginal suppositories and vaginal film6  Cervical mucous (ovulation) method supplemented by calendar in the preovulatory and basal body temperature in the postovulatory phases7  With spermicidal cream or jelly8  Without spermicides9  The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral®* (1 dose is 2 white pills), Alesse®* (1 dose is 5 pink pills), Nordette®* or Levlen®* (1 dose is 2 light orange pills), Lo/Ovral®* (1 dose is 4 white pills), Triphasil®* or Tri-Levlen®* (1 dose is 4 yellow pills)10  However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced or the baby reaches six months of ageClinical StudiesIn a clinical study, 743 women, 18 to 45 years of age, were treated with Lomedia24 Fe for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for Lomedia24 Fe was 1.82.

Which are Lomedia 24 Fe UNII Codes?

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

Which are Lomedia 24 Fe 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:

What is the NDC to RxNorm Crosswalk for Lomedia 24 Fe?

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: 1358762 - norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 1358762 - ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1358762 - ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1359117 - {24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 4 (ferrous fumarate 75 MG Oral Tablet) } Pack
  • RxCUI: 1359117 - Eth estra-Noreth Ac 0.02-1 MG (24) Oral Tablet / Ferr fum 75 MG (4) Oral Tablet 28 Day Pack

* 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".