loperamide hydrochloride and simethicone

Generic: loperamide hydrochloride and simethicone

Labeler: northeast pharma
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride and simethicone
Generic Name loperamide hydrochloride and simethicone
Labeler northeast pharma
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
NORTHEAST PHARMA

Identifiers & Regulatory

Product NDC 80136-384
Product ID 80136-384_dc8efd7a-1632-46ea-8d21-9b443ff6081c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211059
Listing Expiration 2026-12-31
Marketing Start 2021-10-27

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80136384
Hyphenated Format 80136-384

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 (80136-384-24) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

80136-384-24 4 BLISTER PACK in 1 CARTON (80136-384-24) / 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": "dc8efd7a-1632-46ea-8d21-9b443ff6081c", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["d106d8e5-cdbb-4f90-8456-e692ffe7f4e6"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["NORTHEAST PHARMA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (80136-384-24)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "80136-384-24", "marketing_start_date": "20211027"}], "brand_name": "Loperamide Hydrochloride and Simethicone", "product_id": "80136-384_dc8efd7a-1632-46ea-8d21-9b443ff6081c", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "80136-384", "generic_name": "Loperamide Hydrochloride and Simethicone", "labeler_name": "NORTHEAST PHARMA", "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": "20211027", "listing_expiration_date": "20261231"}