loperamide hydrochloride and simethicone (58602-869)

Drug Facts

Product Profile

Brand Name loperamide hydrochloride and simethicone

Generic Name loperamide hydrochloride and simethicone

Labeler aurohealth llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-869

Product ID 58602-869_32e30a2b-c658-49da-a9ff-e94279e7f8d3

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA211059

Listing Expiration 2026-12-31

Marketing Start 2021-02-24

Pharmacologic Class

Physiologic Effect

skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602869

Hyphenated Format 58602-869

Supplemental Identifiers

RxCUI

978001

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 ANDA211059 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

125 mg/1
2 mg/1

source: ndc

Packaging

4 BLISTER PACK in 1 CARTON (58602-869-76) / 6 TABLET in 1 BLISTER PACK
3 BLISTER PACK in 1 CARTON (58602-869-80) / 6 TABLET in 1 BLISTER PACK

source: ndc

Packages (2)

58602-869-76 4 BLISTER PACK in 1 CARTON (58602-869-76) / 6 TABLET in 1 BLISTER PACK 58602-869-80 3 BLISTER PACK in 1 CARTON (58602-869-80) / 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": "32e30a2b-c658-49da-a9ff-e94279e7f8d3", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["769e3cc0-6be9-4ab6-88e1-08803d698ef7"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58602-869-76)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "58602-869-76", "marketing_start_date": "20210224"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (58602-869-80)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "58602-869-80", "marketing_start_date": "20210516"}], "brand_name": "Loperamide Hydrochloride and Simethicone", "product_id": "58602-869_32e30a2b-c658-49da-a9ff-e94279e7f8d3", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "58602-869", "generic_name": "Loperamide Hydrochloride and Simethicone", "labeler_name": "Aurohealth 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": "ANDA211059", "marketing_category": "ANDA", "marketing_start_date": "20210224", "listing_expiration_date": "20261231"}