loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-482
Product ID 50268-482_2b49645c-34d1-c6ab-e063-6394a90aaee5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215579
Listing Expiration 2026-12-31
Marketing Start 2023-04-05

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268482
Hyphenated Format 50268-482

Supplemental Identifiers

RxCUI
978006
UNII
77TI35393C

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 ANDA215579 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-482-15) / 1 CAPSULE in 1 BLISTER PACK (50268-482-11)
source: ndc

Packages (1)

50268-482-15 50 BLISTER PACK in 1 BOX (50268-482-15) / 1 CAPSULE in 1 BLISTER PACK (50268-482-11)

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": "2b49645c-34d1-c6ab-e063-6394a90aaee5", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["f8992723-dd9a-bcf6-e053-6294a90aa65c"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-482-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-482-11)", "package_ndc": "50268-482-15", "marketing_start_date": "20230405"}], "brand_name": "Loperamide Hydrochloride", "product_id": "50268-482_2b49645c-34d1-c6ab-e063-6394a90aaee5", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "50268-482", "generic_name": "loperamide hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA215579", "marketing_category": "ANDA", "marketing_start_date": "20230405", "listing_expiration_date": "20261231"}