Norethindrone And Ethinyl Estradiol And Ferrous Fumarate
NDC 68180-897

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68180-897?
  5. Norethindrone And Ethinyl Estradiol And Ferrous Fumarate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Norethindrone And Ethinyl Estradiol And Ferrous Fumarate is a NDA AUTHORIZED GENERIC-approved product labeled by Lupin Pharmaceuticals, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 68180-897 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
68180-897
Proprietary Name:
Norethindrone And Ethinyl Estradiol And Ferrous Fumarate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Lupin Pharmaceuticals, Inc.
Labeler Code:
68180
Product Label ID:
f704dd21-68d1-4697-b07f-4e07a8a9c29c
FDA Application Number: [6]
NDA021490
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

Marketing Timeline

Start Marketing Date: [9]
10-04-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325)
BROWN (C48332)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
WC;581
PD;622
Score:
1

Code Structure Chart

Product Details

What is NDC 68180-897?

The NDC code 68180-897 is assigned by the FDA to the product Norethindrone And Ethinyl Estradiol And Ferrous Fumarate. This pharmaceutical product is labeled by Lupin Pharmaceuticals, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 68180-897-13. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.Oral contraceptives are highly effective. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE 2 Percentage 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 One Year3Method (1)Typical Use1(2)Perfect Use2(3)(4)Chance48585Spermicides526 640Periodic abstinence2563      Calendar 9      Ovulation Method 3      Sympto-thermal6 2      Post-Ovulation 1Cap7      Parous Women402642      Nulliparous Women20 956Sponge      Parous Women402042      Nulliparous Women20 956Diaphragm720 656Withdrawal19 4Condom8      Female (reality)21 556      Male14 361Pill 571      Progestin only0.5      Combined0.1IUD      Progesterone T2.01.581      Copper T 380A0.80.678      LNg 200.10.181Depo-Provera®0.30.370Norplant® and Norplant® 20.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Emergency 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 contraception10Source: 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 age

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 1095223 - ferrous fumarate 75 MG Chewable Tablet
  • RxCUI: 1095224 - {21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack
  • RxCUI: 1095224 - eth-estra-noreth 0.035-0.4 MG (21) Chewable Tablet / ferr fum 75 MG (7) Chewable Tablet 28 Day Pack
  • RxCUI: 1095224 - {21 (ethinyl estradiol 35 MCG / norethindrone 0.4 MG Chewable Tablet) / 7 (ferrous fumarate 75 MG Chewable Tablet) } Pack
  • RxCUI: 433718 - norethindrone 0.4 MG / ethinyl estradiol 35 MCG Chewable Tablet

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".