loperamide hydrochloride and simethicone (69452-210)

Drug Facts

Product Profile

Brand Name loperamide hydrochloride and simethicone

Generic Name loperamide hydrochloride and simethicone

Labeler bionpharma inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-210

Product ID 69452-210_45c4a3fe-23d5-2584-e063-6394a90a1be7

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA213484

Listing Expiration 2026-12-31

Marketing Start 2021-12-01

Pharmacologic Class

Physiologic Effect

skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452210

Hyphenated Format 69452-210

Supplemental Identifiers

RxCUI

978001

UPC

0369452210048

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 ANDA213484 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

125 mg/1
2 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (69452-210-04) / 6 TABLET in 1 BLISTER PACK
4 BLISTER PACK in 1 CARTON (69452-210-12) / 6 TABLET in 1 BLISTER PACK

source: ndc

Packages (2)

69452-210-04 1 BLISTER PACK in 1 CARTON (69452-210-04) / 6 TABLET in 1 BLISTER PACK 69452-210-12 4 BLISTER PACK in 1 CARTON (69452-210-12) / 6 TABLET in 1 BLISTER PACK

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": "45c4a3fe-23d5-2584-e063-6394a90a1be7", "openfda": {"nui": ["N0000010282"], "upc": ["0369452210048"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["9b0a802f-6fae-4142-ad2f-4b16ed67400e"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69452-210-04)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "69452-210-04", "marketing_start_date": "20211219"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (69452-210-12)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "69452-210-12", "marketing_start_date": "20211219"}], "brand_name": "Loperamide hydrochloride and Simethicone", "product_id": "69452-210_45c4a3fe-23d5-2584-e063-6394a90a1be7", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "69452-210", "generic_name": "loperamide hydrochloride and simethicone", "labeler_name": "Bionpharma Inc.", "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": "ANDA213484", "marketing_category": "ANDA", "marketing_start_date": "20211201", "listing_expiration_date": "20261231"}