PillNorethindrone Acetate And Ethinyl Estradiol
Brands: Aurovela 1.5/30 · Aurovela 1/20 · Hailey 1.5/30 · Jinteli +4 · Ethinyl Estradiol + Norethindrone Acetate
9 active makers
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US acquisition costNADAC · per unit
Average across 15 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it9 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | unknown | 6 | SUPPLYING |
| Nivagen Pharmaceuticals, Inc. | unknown | 4 | SUPPLYING |
| Teva Pharmaceuticals USA, Inc. | unknown | 4 | SUPPLYING |
| Aurobindo Pharma Limited | unknown | 4 | SUPPLYING |
| Xiromed, LLC. | unknown | 2 | SUPPLYING |
| Mylan Pharmaceuticals Inc. | unknown | 2 | SUPPLYING |
| Teva Women's Health LLC | unknown | 2 | SUPPLYING |
| A-S Medication Solutions | unknown | 1 | SUPPLYING |
| Proficient Rx LP | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jan 30, 2017RECALLRecall (Class III): Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-…
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room. — Recalling firm: Mylan Pharmaceuticals Inc. — Nationwide in USA
- Mar 15, 2013RECALLRecall (Class III): Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day reg…
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing — Recalling firm: Teva Pharmaceuticals USA, Inc. — Nationwide distribution. No foreign or government accounts.