loperamide hydrochloride, simethicone

Generic: loperamide hydrochloride, simethicone

Labeler: guardian drug company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride, simethicone
Generic Name loperamide hydrochloride, simethicone
Labeler guardian drug company
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Guardian Drug Company

Identifiers & Regulatory

Product NDC 53041-263
Product ID 53041-263_289e6064-8eb8-4b56-bc9e-ee82ad83674f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA214541
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53041263
Hyphenated Format 53041-263

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, simethicone (source: ndc)
Generic Name loperamide hydrochloride, simethicone (source: ndc)
Application Number ANDA214541 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

53041-263-50 1 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Loperamide Hydrochloride, Simethicone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "289e6064-8eb8-4b56-bc9e-ee82ad83674f", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["1b79204e-8a99-455b-84d6-f381fd7d1135"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (53041-263-50)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "53041-263-50", "marketing_start_date": "20210601"}], "brand_name": "Loperamide Hydrochloride, Simethicone", "product_id": "53041-263_289e6064-8eb8-4b56-bc9e-ee82ad83674f", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "53041-263", "generic_name": "Loperamide Hydrochloride, Simethicone", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loperamide Hydrochloride, Simethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}, {"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA214541", "marketing_category": "ANDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}