NDC 68968-0514
CombiPatch (estradiol/norethindrone acetate transdermal system) 0.05 mg per 1 d / 0.14 mg per 1 d patch, extended release
On the label: Noven Therapeutics, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Noven Pharmaceuticals, Inc. | Miami, FL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2026 · 11 inspections, 2 with FDA action |
Recalls
- Jul 30, 2021 · Class II · Noven Pharmaceuticals Inc
Failed Stability Specifications; out of specification for shear.
Lots: Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022 - Jul 30, 2021 · Class II · Noven Pharmaceuticals Inc
Failed Stability Specifications; out of specification for shear.
Lots: Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Estradiol and Norethindrone: every company that makes it
- Form
- patch, extended release, transdermal
- Strength
- 0.05 mg per 1 d / 0.14 mg per 1 d
- Approval
- NDA NDA020870
- On the market since
- Aug 7, 1998
- Package NDCs
68968-0514-8- Official label
- DailyMed (National Library of Medicine), updated Feb 21, 2024
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