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 SUSPENSION
Routes
ORAL
Active Ingredients

loperamide hydrochloride 1 mg/7.5mL

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0418
Product ID 70000-0418_9172bc2f-a9c3-4b2d-9f88-ea9f94491063
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091292
Listing Expiration 2026-12-31
Marketing Start 2018-08-13

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000418
Hyphenated Format 70000-0418

Supplemental Identifiers

RxCUI
1250685
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 ANDA091292 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/7.5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (70000-0418-1)
source: ndc

Packages (1)

70000-0418-1 120 mL in 1 BOTTLE (70000-0418-1)

Ingredients (1)

loperamide hydrochloride (1 mg/7.5mL)

Linked Drug Pages (1)

leader anti diarrheal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9172bc2f-a9c3-4b2d-9f88-ea9f94491063", "openfda": {"unii": ["77TI35393C"], "rxcui": ["1250685"], "spl_set_id": ["f845fad8-6b3c-4c7e-94bc-d4f99f69e4f0"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (70000-0418-1)", "package_ndc": "70000-0418-1", "marketing_start_date": "20180813"}], "brand_name": "leader anti diarrheal", "product_id": "70000-0418_9172bc2f-a9c3-4b2d-9f88-ea9f94491063", "dosage_form": "SUSPENSION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "70000-0418", "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": "1 mg/7.5mL"}], "application_number": "ANDA091292", "marketing_category": "ANDA", "marketing_start_date": "20180813", "listing_expiration_date": "20261231"}