loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8497
Product ID 0615-8497_96819325-1225-4982-8e6a-85b217a6b6d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216876
Listing Expiration 2026-12-31
Marketing Start 2023-01-26

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158497
Hyphenated Format 0615-8497

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 ANDA216876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (0615-8497-39)
source: ndc

Packages (1)

0615-8497-39 30 CAPSULE in 1 BLISTER PACK (0615-8497-39)

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": "96819325-1225-4982-8e6a-85b217a6b6d8", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["f245e8f4-e06e-492e-8c46-af1fce1633fc"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (0615-8497-39)", "package_ndc": "0615-8497-39", "marketing_start_date": "20240112"}], "brand_name": "Loperamide Hydrochloride", "product_id": "0615-8497_96819325-1225-4982-8e6a-85b217a6b6d8", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0615-8497", "generic_name": "Loperamide Hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA216876", "marketing_category": "ANDA", "marketing_start_date": "20230126", "listing_expiration_date": "20261231"}