# Loperamide Hydrochloride and Simethicone

NDC: 84441-713
Generic name: Loperamide Hydrochloride and Simethicone
Labeler / Manufacturer: IMO-GEN LABS LLC
Product type: HUMAN OTC DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: ORAL
Marketing started: 20251023

FDA application: ANDA211438

## 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:"84441-713"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=84441-713
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=41d6dba5-e411-c8d2-e063-6294a90ae8fa