NDC 53002-2666
Budesonide and Formoterol Fumarate Dihydrate 80 ug / 4.5 ug aerosol
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from AstraZeneca Pharmaceuticals LP's NDC 0310-7372.
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 AstraZeneca Pharmaceuticals LP names for other drugs.
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · relabels it
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 2000655C00
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Budesonide and Formoterol: every company that makes it
- Form
- aerosol
- Strength
- 80 ug / 4.5 ug
- Approval
- NDA authorized generic NDA021929
- On the market since
- Jan 3, 2020
- Package NDCs
53002-2666-1- Official label
- DailyMed (National Library of Medicine), updated Mar 30, 2022
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