NDC 54868-4045 Necon 1/35

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:
54868-4045
Proprietary Name:
Necon 1/35
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
54868
Start Marketing Date: [9]
08-10-2001
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - DARK YELLOW)
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
5 MM
Imprint(s):
WATSON;508
WATSON;P
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-4045?

The NDC code 54868-4045 is assigned by the FDA to the product Necon 1/35 which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-4045-0 1 blister pack in 1 pouch / 1 kit in 1 blister pack. 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 Necon 1/35?

Necon® 1/35, Necon® 0.5/35, Necon® 10/11, and Necon® 1/50 are 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 I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE I: 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 anUnintended Pregnancywithin the First Year of Use% of WomenContinuing Useat One Year3 Method(1)Typical Use1 (2)Perfect Use2 (3)(4)Adapted from Hatcher et al., 1998 Ref. #1.1 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.Chance4 8585Spermicides5 26  640Periodic abstinence 2563  Calendar  9  Ovulation Method  3  Sympto-Thermal6   2  Post-Ovulation  1Withdrawal 19  4Cap7   Parous Women402642  Nulliparous Women 20  956Sponge  Parous Women402042  Nulliparous Women 20  956Diaphragm7 20  656Condom8   Female (Reality)21  556  Male14  361Pill  571  Progestin Only      0.5  Combined      0.1IUD  Progesterone T      2.0      1.581  Copper T380A      0.8      0.678  LNg 20      0.1      0.181Depo–Provera      0.3      0.370Norplant and Norplant-2        0.05        0.0588Female Sterilization      0.5      0.5100Male Sterilization         0.15        0.10100

Which are Necon 1/35 UNII Codes?

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

Which are Necon 1/35 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 Necon 1/35?

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:

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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".