FDA label
What is Nortrel used for?
Nortrel contains norethindrone and ethinyl estradiol. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Nortrel 1/35 and Nortrel 0.5/35 Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.”
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Nortrel, tablet
Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA072693). Cross-references to other label sections are left out.
Nortrel 1/35 and Nortrel 0.5/35 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 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.
Nortrel 0.5/35 and 1/35 have not been studied for and are not indicated for use in emergency contraception.
Source: DailyMed label, set id 140c50d6-c931-423a-9aa0-526eae7ab93c, version 16, effective December 1, 2021. NDC 0555-9009, one of 1 listing for this product.
Questions
What is Nortrel used for?
The FDA label says: “Nortrel 1/35 and Nortrel 0.5/35 Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.”
What drug class is Nortrel?
FDA lists norethindrone and ethinyl estradiol in the Estrogen and Progestin established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Nortrel
- Is Nortrel a controlled substance?Federal schedule
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- Generic for Ortho-novum 7/7/7-21FDA Orange Book
- Generic for Ovcon-35FDA Orange Book
- Generic for Brevicon 28-dayFDA Orange Book
- Generic for Norinyl 1+35 28-dayFDA Orange Book
- Generic for Ortho-novum 1/35-28FDA Orange Book
- Generic for Ortho-novum 10/11-28FDA Orange Book
- Generic for Ortho-novum 7/14-28FDA Orange Book
- Generic for Ortho-novum 7/7/7-28FDA Orange Book
- Estrogens listFDA drug class
- Progestins listFDA drug class
- NDC 0555-9009Nortrel NDC record