loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-691
Product ID 59651-691_8d142533-4e87-4030-8fe9-4fc7473b0442
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218122
Listing Expiration 2026-12-31
Marketing Start 2023-09-05

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651691
Hyphenated Format 59651-691

Supplemental Identifiers

RxCUI
978006
UPC
0359651691014
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 (source: ndc)
Generic Name loperamide hydrochloride (source: ndc)
Application Number ANDA218122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (59651-691-01)
  • 500 CAPSULE in 1 BOTTLE (59651-691-05)
source: ndc

Packages (2)

59651-691-01 100 CAPSULE in 1 BOTTLE (59651-691-01) 59651-691-05 500 CAPSULE in 1 BOTTLE (59651-691-05)

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

LOPERAMIDE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8d142533-4e87-4030-8fe9-4fc7473b0442", "openfda": {"upc": ["0359651691014"], "unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["8d142533-4e87-4030-8fe9-4fc7473b0442"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (59651-691-01)", "package_ndc": "59651-691-01", "marketing_start_date": "20230905"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (59651-691-05)", "package_ndc": "59651-691-05", "marketing_start_date": "20230905"}], "brand_name": "LOPERAMIDE HYDROCHLORIDE", "product_id": "59651-691_8d142533-4e87-4030-8fe9-4fc7473b0442", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "59651-691", "generic_name": "LOPERAMIDE HYDROCHLORIDE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LOPERAMIDE HYDROCHLORIDE", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA218122", "marketing_category": "ANDA", "marketing_start_date": "20230905", "listing_expiration_date": "20261231"}