anti-diarrheal

Generic: loperamide hcl

Labeler: l.n.k. international, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti-diarrheal
Generic Name loperamide hcl
Labeler l.n.k. international, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
L.N.K. International, Inc.

Identifiers & Regulatory

Product NDC 50844-259
Product ID 50844-259_60b41d57-99b5-4cea-a996-58bd515fb65a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076497
Listing Expiration 2026-12-31
Marketing Start 2019-07-15

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50844259
Hyphenated Format 50844-259

Supplemental Identifiers

RxCUI
978010
UPC
0052548689780
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 anti-diarrheal (source: ndc)
Generic Name loperamide hcl (source: ndc)
Application Number ANDA076497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (50844-259-02) / 6 TABLET 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": "60b41d57-99b5-4cea-a996-58bd515fb65a", "openfda": {"upc": ["0052548689780"], "unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["c03a9389-8b33-4ade-8ba0-8f303e161a08"], "manufacturer_name": ["L.N.K. International, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50844-259-02)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "50844-259-02", "marketing_start_date": "20190715"}], "brand_name": "Anti-Diarrheal", "product_id": "50844-259_60b41d57-99b5-4cea-a996-58bd515fb65a", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "50844-259", "generic_name": "Loperamide HCl", "labeler_name": "L.N.K. International, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anti-Diarrheal", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA076497", "marketing_category": "ANDA", "marketing_start_date": "20190715", "listing_expiration_date": "20261231"}