Cyclafem 1/35
NDC 76413-105

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 76413-105?
  5. Cyclafem 1/35 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.

Cyclafem 1/35 is a ANDA-approved product labeled by Central Texas Community Health Centers. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a pink product. This product entry covers the primary NDC 76413-105 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
76413-105
Proprietary Name:
Cyclafem 1/35
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Central Texas Community Health Centers
Labeler Code:
76413
Product Label ID:
c91c8c31-4806-449e-bfe5-fa5c615252dc
FDA Application Number: [6]
ANDA076337
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-12-2010
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I

Product Characteristics

Color(s):
PINK (C48328)
GREEN (C48329 - LIGHT-GREEN)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
93;742
93;743
Score:
1

Code Structure Chart

Product Details

What is NDC 76413-105?

The NDC code 76413-105 is assigned by the FDA to the product Cyclafem 1/35. This pharmaceutical product is labeled by Central Texas Community Health Centers 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: 76413-105-28. 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?

Cyclafem™ 1/35 (norethindrone and ethinyl estradiol tablets USP) 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 1 lists the typical accidental pregnancy rates for users of combined 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 1: 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.Method (1) % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3  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 56Withdrawal19 4  Condom8   Female (Reality®) 21 5 56Male 14 3 61Pill 5  71Progestin Only  0.5 Combined  0.1 IUD   Progesterone T 2.0 1.5 81Copper T380A 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 0.5 100Male Sterilization 0.150.10  100Adapted from Hatcher et al., 1998, Ref. #1.Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10Source: Trussell J, 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 reason. 2 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 reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant 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% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides.9 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.Cyclafem™ 1/35 has not been studied for and is not indicated for use in emergency contraception. 

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: 1047040 - {21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cyclafem 1/35 28 Day]
  • RxCUI: 1047040 - Cyclafem 1/35 28 Day Pack
  • RxCUI: 312033 - norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet
  • RxCUI: 312033 - ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet
  • RxCUI: 312033 - ethinyl estradiol 35 MCG / norethindrone 1 MG Oral 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".