# Loperamide hydrochloride and Simethicone

NDC: 69452-531
Generic name: loperamide hydrochloride and simethicone
Labeler / Manufacturer: Bionpharma Inc.
Product type: HUMAN OTC DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: ORAL
Marketing started: 20260107

FDA application: ANDA213484

## Active ingredients

- DIMETHICONE: 125 mg/1
- LOPERAMIDE HYDROCHLORIDE: 2 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"69452-531"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=69452-531
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=47a779c7-c709-6208-e063-6394a90a6dfa