loperamide hydrochloride 2mg (25000-001)

Drug Facts

Product Profile

Brand Name loperamide hydrochloride 2mg

Generic Name loperamide hydrochloride tablets usp, 2mg

Labeler marksans pharma limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer

MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-001

Product ID 25000-001_2081729a-e6bb-44b8-8295-b7810b77df5e

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA220153

Listing Expiration 2026-12-31

Marketing Start 2025-11-19

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25000001

Hyphenated Format 25000-001

Supplemental Identifiers

RxCUI

978010

UPC

0325000001834

UNII

77TI35393C

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 2mg (source: ndc)

Generic Name loperamide hydrochloride tablets usp, 2mg (source: ndc)

Application Number ANDA220153 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2 mg/1

source: ndc

Packaging

4 BLISTER PACK in 1 CARTON (25000-001-83) / 6 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

25000-001-83 4 BLISTER PACK in 1 CARTON (25000-001-83) / 6 TABLET in 1 BLISTER PACK

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Loperamide Hydrochloride 2mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2081729a-e6bb-44b8-8295-b7810b77df5e", "openfda": {"upc": ["0325000001834"], "unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["644fb37a-1d97-4333-a5c7-5a485ab338f7"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (25000-001-83)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "25000-001-83", "marketing_start_date": "20251119"}], "brand_name": "Loperamide Hydrochloride 2mg", "product_id": "25000-001_2081729a-e6bb-44b8-8295-b7810b77df5e", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "25000-001", "generic_name": "Loperamide Hydrochloride Tablets USP, 2mg", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loperamide Hydrochloride 2mg", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA220153", "marketing_category": "ANDA", "marketing_start_date": "20251119", "listing_expiration_date": "20261231"}