Two medicines, side by side
Ethinyl estradiol/levonorgestrel vs ethinyl estradiol/norethindrone
Ethinyl estradiol/levonorgestrel and ethinyl estradiol/norethindrone are both labeled for birth control. Drugs@FDA records approvals of ethinyl estradiol/levonorgestrel since 1982 and of ethinyl estradiol/norethindrone since 1973. Pharmacies paid $0.154 per falmina-28 tablet and $0.181 per microgestin 21 1-20 tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Ethinyl estradiol/norethindrone's other strengths are brand-only: $7.04 per unit (Femlyv 1 mg-0.02 mg ODT). In FDA's classes, ethinyl estradiol/levonorgestrel is a progestin-containing intrauterine system and ethinyl estradiol/norethindrone an estrogen.
Check it at the source: the ethinyl estradiol/levonorgestrel FDA label on DailyMed (effective August 27, 2026); the ethinyl estradiol/norethindrone FDA label on DailyMed (effective November 18, 2025).
Highlights of the ethinyl estradiol and levonorgestrel record
Ethinyl estradiol and levonorgestrel (Twirla) · label of August 27, 2026
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.
Used for
From the label: indicationsTYBLUME is indicated for use by females of reproductive potential to prevent pregnancy. TYBLUME (levonorgestrel and ethinyl estradiol tablets) is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
On the market
- Earliest approval on file
- May 10, 1982
- Generic labelers
- 19 labelers
- Pharmacy cost
- $0.154 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 9
Highlights of the ethinyl estradiol and norethindrone record
Ethinyl estradiol and norethindrone (Nortrel) · label of November 18, 2025
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Blisovi Fe 1/20, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS).
Used for
From the label: indicationsBlisovi Fe 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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. […]
On the market
- Earliest approval on file
- April 30, 1973
- Generic labelers
- 18 labelers
- Pharmacy cost
- $0.181 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 8
Source: FDA drug labels via openFDA (Ethinyl estradiol/levonorgestrel label of August 27, 2026, Ethinyl estradiol/norethindrone label of November 18, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do ethinyl estradiol/levonorgestrel and ethinyl estradiol/norethindrone differ on the record?
In FDA's classes, ethinyl estradiol/levonorgestrel is a progestin-containing intrauterine system and ethinyl estradiol/norethindrone an estrogen.
Both labels carry a boxed warning; the records quote them.
Generics: ethinyl estradiol/levonorgestrel since 1993; ethinyl estradiol/norethindrone since 1987 (Drugs@FDA).
| Ethinyl estradiol/levonorgestrel | Ethinyl estradiol/norethindrone | |
|---|---|---|
| Labeled for | Birth control | Birth control, Osteoporosis, Menopause symptoms, Acne |
| Pharmacologic class | Estrogen, Progestin, Progestin-containing Intrauterine System | Estrogen, Progestin |
| How it works (label) | CHCs lower the risk of becoming pregnant primarily by suppressing ovulation. | n/a |
| Half-life (label) | Excretion The elimination half-life for levonorgestrel is approximately 36 ± 13 hours at steady state. | n/a |
| Earliest approval on file (Drugs@FDA) | May 10, 1982 | April 30, 1973 |
| First generic approved | December 13, 1993 | January 29, 1987 |
| Generic labelers (NDC) | 19 labelers | 18 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.154 per tablet (Falmina-28 tablet) | $0.181 per tablet (Microgestin 21 1-20 tablet) |
| 12-month price change | -2% | +5% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 9 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 3,159 | 3,631 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to ethinyl estradiol/levonorgestrel
- every medicine labeled for the same conditions