NDC 61919-787
Bisoprolol Fumarate 5 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Unichem Pharmaceuticals (USA), Inc.'s NDC 29300-126.
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 Unichem Pharmaceuticals (USA), Inc. names for other drugs.
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Oct 2, 2017 · Class II · Unichem Pharmaceuticals Usa Inc
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Lots: Lot #: GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp 03/31/2018.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bisoprolol: every company that makes it
- Form
- tablet
- Strength
- 5 mg
- Approval
- ANDA ANDA078635
- On the market since
- Mar 21, 2019
- Package NDCs
61919-787-90- Official label
- DailyMed (National Library of Medicine), updated Mar 21, 2019
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