Two medicines, side by side
Ethinyl estradiol/levonorgestrel vs ethinyl estradiol/norgestimate
Ethinyl estradiol/levonorgestrel and ethinyl estradiol/norgestimate are both labeled for birth control. Drugs@FDA records approvals of ethinyl estradiol/levonorgestrel since 1982 and of ethinyl estradiol/norgestimate since 1989. Pharmacies paid $0.154 per falmina-28 tablet and $0.115 per mili 0.25-0.035 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.
Check it at the source: the ethinyl estradiol/levonorgestrel FDA label on DailyMed (effective August 27, 2026); the ethinyl estradiol/norgestimate FDA label on DailyMed (effective February 6, 2026).
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 norgestimate record
Ethinyl estradiol and norgestimate (Sprintec) · label of February 6, 2026
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 are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 )].
Used for
From the label: indicationsNorgestimate and ethinyl estradiol tablets are combinations of norgestimate, 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
- December 29, 1989
- Generic labelers
- 18 labelers
- Pharmacy cost
- $0.115 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 3
Source: FDA drug labels via openFDA (Ethinyl estradiol/levonorgestrel label of August 27, 2026, Ethinyl estradiol/norgestimate label of February 6, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do ethinyl estradiol/levonorgestrel and ethinyl estradiol/norgestimate differ on the record?
How each works, in its label's words: Ethinyl estradiol/levonorgestrel, “CHCs lower the risk of becoming pregnant primarily by suppressing ovulation.”; Ethinyl estradiol/norgestimate, “Oral Contraception COCs lower the risk of becoming pregnant primarily by suppressing ovulation. • Acne Acne is a skin condition with a multifactorial etiology, including androgen stimulation of sebum …”
Both labels carry a boxed warning; the records quote them.
Generics: ethinyl estradiol/levonorgestrel since 1993; ethinyl estradiol/norgestimate since 2002 (Drugs@FDA).
| Ethinyl estradiol/levonorgestrel | Ethinyl estradiol/norgestimate | |
|---|---|---|
| Labeled for | Birth control | Acne, Birth control |
| Pharmacologic class | Estrogen, Progestin, Progestin-containing Intrauterine System | n/a |
| How it works (label) | CHCs lower the risk of becoming pregnant primarily by suppressing ovulation. | Oral Contraception COCs lower the risk of becoming pregnant primarily by suppressing ovulation. • Acne Acne is a skin condition with a multifactorial etiology, including androgen stimulation of sebum production. |
| 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 | December 29, 1989 |
| First generic approved | December 13, 1993 | September 25, 2002 |
| 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) | $0.115 per tablet (Mili 0.25-0.035 mg tablet) |
| 12-month price change | -2% | -10% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 9 | 3 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 3,159 | 4,557 |
| 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