loperamide hydrochloride and simethicone (84441-713)

Drug Facts

Product Profile

Brand Name loperamide hydrochloride and simethicone

Generic Name loperamide hydrochloride and simethicone

Labeler imo-gen labs llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

dimethicone 125 mg/1, loperamide hydrochloride 2 mg/1

Manufacturer

IMO-GEN LABS LLC

Identifiers & Regulatory

Product NDC 84441-713

Product ID 84441-713_41d6dba5-e412-c8d2-e063-6294a90ae8fa

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA211438

Listing Expiration 2026-12-31

Marketing Start 2025-10-23

Pharmacologic Class

Physiologic Effect

skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84441713

Hyphenated Format 84441-713

Supplemental Identifiers

RxCUI

978001

UPC

0860010278123

UNII

92RU3N3Y1O 77TI35393C

NUI

N0000010282

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name loperamide hydrochloride and simethicone (source: ndc)

Generic Name loperamide hydrochloride and simethicone (source: ndc)

Application Number ANDA211438 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

125 mg/1
2 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (84441-713-10)

source: ndc

Packages (1)

84441-713-10 100 TABLET in 1 BOTTLE (84441-713-10)

Ingredients (2)

dimethicone (125 mg/1) loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Loperamide Hydrochloride and Simethicone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "41d6dba5-e412-c8d2-e063-6294a90ae8fa", "openfda": {"nui": ["N0000010282"], "upc": ["0860010278123"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["41d6dba5-e411-c8d2-e063-6294a90ae8fa"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["IMO-GEN LABS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (84441-713-10)", "package_ndc": "84441-713-10", "marketing_start_date": "20251023"}], "brand_name": "Loperamide Hydrochloride and Simethicone", "product_id": "84441-713_41d6dba5-e412-c8d2-e063-6294a90ae8fa", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "84441-713", "generic_name": "Loperamide Hydrochloride and Simethicone", "labeler_name": "IMO-GEN LABS LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loperamide Hydrochloride and Simethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}, {"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA211438", "marketing_category": "ANDA", "marketing_start_date": "20251023", "listing_expiration_date": "20261231"}