loperamide hcl

Generic: loperamide hcl

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

Drug Facts

Product Profile

Brand Name loperamide hcl
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 50844-735
Product ID 50844-735_cb21f56f-f513-4fa1-817c-0e5c3ce660c5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076497
Listing Expiration 2026-12-31
Marketing Start 2005-05-03

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50844735
Hyphenated Format 50844-735

Supplemental Identifiers

RxCUI
978010
UPC
0350844735089
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 hcl (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 (50844-735-02) / 6 TABLET in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (50844-735-08) / 6 TABLET in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (50844-735-19) / 4 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (50844-735-24) / 2 TABLET in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (50844-735-44) / 6 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (50844-735-45) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (6)

50844-735-02 2 BLISTER PACK in 1 CARTON (50844-735-02) / 6 TABLET in 1 BLISTER PACK 50844-735-08 4 BLISTER PACK in 1 CARTON (50844-735-08) / 6 TABLET in 1 BLISTER PACK 50844-735-19 2 BLISTER PACK in 1 CARTON (50844-735-19) / 4 TABLET in 1 BLISTER PACK 50844-735-24 1 BLISTER PACK in 1 CARTON (50844-735-24) / 2 TABLET in 1 BLISTER PACK 50844-735-44 3 BLISTER PACK in 1 CARTON (50844-735-44) / 6 TABLET in 1 BLISTER PACK 50844-735-45 1 BLISTER PACK in 1 CARTON (50844-735-45) / 6 TABLET in 1 BLISTER PACK

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Loperamide HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cb21f56f-f513-4fa1-817c-0e5c3ce660c5", "openfda": {"upc": ["0350844735089"], "unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["547c4197-f573-4b30-9e39-2ab11d343609"], "manufacturer_name": ["L.N.K. International, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50844-735-02)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "50844-735-02", "marketing_start_date": "20050503"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (50844-735-08)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "50844-735-08", "marketing_start_date": "20050503"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50844-735-19)  / 4 TABLET in 1 BLISTER PACK", "package_ndc": "50844-735-19", "marketing_start_date": "20050503"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50844-735-24)  / 2 TABLET in 1 BLISTER PACK", "package_ndc": "50844-735-24", "marketing_start_date": "20050503"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (50844-735-44)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "50844-735-44", "marketing_start_date": "20050503"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50844-735-45)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "50844-735-45", "marketing_start_date": "20050503"}], "brand_name": "Loperamide HCl", "product_id": "50844-735_cb21f56f-f513-4fa1-817c-0e5c3ce660c5", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "50844-735", "generic_name": "Loperamide HCl", "labeler_name": "L.N.K. International, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loperamide HCl", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA076497", "marketing_category": "ANDA", "marketing_start_date": "20050503", "listing_expiration_date": "20261231"}