NDC 53002-1725
Balziva 0.4 mg / 0.035 mg kit
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Teva Pharmaceuticals USA, Inc.'s NDC 0555-9034.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Teva Pharmaceuticals USA, Inc. names for other drugs.
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 100016785 - Mar 15, 2013 · Class III · Teva Pharmaceuticals USA, Inc.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Lots: NDC 0555-9034-58, Lot numbers 33802100A, exp 3/2013; 33802266A, exp 3/2013; and 33802832A, exp 8/2013.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ethinyl Estradiol and Norethindrone: every company that makes it
- Form
- kit
- Strength
- 0.4 mg / 0.035 mg
- Approval
- ANDA ANDA076238
- On the market since
- Oct 16, 2006
- Package NDCs
53002-1725-1- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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