leader anti diarrheal

Generic: loperamide hcl

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leader anti diarrheal
Generic Name loperamide hcl
Labeler cardinal health 110, llc. dba leader
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0225
Product ID 70000-0225_dd0ee798-d323-4d39-a04c-d2e10df1cd2f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075232
Listing Expiration 2026-12-31
Marketing Start 2017-01-17

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000225
Hyphenated Format 70000-0225

Supplemental Identifiers

RxCUI
978010
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 leader anti diarrheal (source: ndc)
Generic Name loperamide hcl (source: ndc)
Application Number ANDA075232 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (70000-0225-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "dd0ee798-d323-4d39-a04c-d2e10df1cd2f", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["9079a59b-a158-4e77-a104-547959f7ba78"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (70000-0225-2)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70000-0225-2", "marketing_start_date": "20200202"}], "brand_name": "Leader Anti Diarrheal", "product_id": "70000-0225_dd0ee798-d323-4d39-a04c-d2e10df1cd2f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "70000-0225", "generic_name": "Loperamide HCl", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Anti Diarrheal", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA075232", "marketing_category": "ANDA", "marketing_start_date": "20170117", "listing_expiration_date": "20261231"}