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Sold as Norlutate, Aygestin. Every FDA application for this active ingredient: 2 branded and 6 generic.
As of Nov 15, 2026, FDA lists 8 applications for Norethindrone Acetate (sold as Norlutate, Aygestin), first approved Apr 21, 1982, with 0 new uses approved and 0 published complete response letters.
First approved: Apr 21, 1982
Applications: 8
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $2.6M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Norethindrone Acetate
Part D
$2.2M
-8%
15,277
Gallifrey
Part D
$412K
+1348%
4,470
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
NORETHINDRONE 0.35 MG TABLET: $0.098 per unitGeneric · +9% in a year
NORETHINDRONE 5 MG TABLET: $0.290 per unitGeneric · -4% in a year
Clinical Trials
15 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Parke Davis