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  5. NDC Package Code: 16714-348-02 Dasetta 1/35

NDC Package 16714-348-02 Dasetta 1/35

Norethindrone And Ethinyl Estradiol Kit Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
16714-348-02
Package Description:
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code:
16714-348
Proprietary Name:
Dasetta 1/35
Non-Proprietary Name:
Norethindrone And Ethinyl Estradiol
Usage Information:
DASETTA™ 1/35 Tablets 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 1 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, 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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3MethodTypical Use1Perfect Use2(1)(2)(3)(4)Chance48585Spermicides526640Periodic abstinence2563 Calendar9 Ovulation Method3 Sympto-Thermal62 Post-Ovulation1Cap7 Parous Women402642 Nulliparous Women20956Sponge Parous Women402042 Nulliparous Women20956Diaphragm720656Withdrawal194Condom8 Female (Reality®)21556 Male14361Pill571 Progestin Only0.5 Combined0.1IUD Progesterone T2.01.581 Copper T380A0.80.678 LNg 200.10.181Depo-Provera®0.30.370Norplant® and Norplant-2®0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Adapted 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 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.DASETTA™ 1/35 has not been studied for and is not indicated for use in emergency contraception.
11-Digit NDC Billing Format:
16714034802
NDC to RxNorm Crosswalk:
  • RxCUI: 1300538 - {21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Dasetta 1/35 28 Day]
  • RxCUI: 1300538 - DASETTA 1/35 28 Day Pack
  • RxCUI: 1300538 - Dasetta 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Northstar Rx Llc
    Dosage Form:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Sample Package:
    No
    FDA Application Number:
    ANDA090948
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-22-2011
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    16714-348-011 BLISTER PACK in 1 PACKET / 1 KIT in 1 BLISTER PACK
    16714-348-033 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
    16714-348-046 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 16714-348-02?

    The NDC Packaged Code 16714-348-02 is assigned to a package of 1 blister pack in 1 carton / 1 kit in 1 blister pack of Dasetta 1/35, a human prescription drug labeled by Northstar Rx Llc. The product's dosage form is kit and is administered via oral form.

    Is NDC 16714-348 included in the NDC Directory?

    Yes, Dasetta 1/35 with product code 16714-348 is active and included in the NDC Directory. The product was first marketed by Northstar Rx Llc on December 22, 2011 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 16714-348-02?

    The 11-digit format is 16714034802. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-216714-348-025-4-216714-0348-02