loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler a-s medication solutions
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7398
Product ID 50090-7398_fdda3cf0-8782-474c-95a7-5990383112f3
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 500907398
Hyphenated Format 50090-7398

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 ANDA218122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 15 CAPSULE in 1 BOTTLE (50090-7398-0)
  • 12 CAPSULE in 1 BOTTLE (50090-7398-3)
  • 30 CAPSULE in 1 BOTTLE (50090-7398-4)
source: ndc

Packages (3)

50090-7398-0 15 CAPSULE in 1 BOTTLE (50090-7398-0) 50090-7398-3 12 CAPSULE in 1 BOTTLE (50090-7398-3) 50090-7398-4 30 CAPSULE in 1 BOTTLE (50090-7398-4)

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": "fdda3cf0-8782-474c-95a7-5990383112f3", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["d572ecf7-ddc3-46fb-80a6-80b7b1b90a1b"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "15 CAPSULE in 1 BOTTLE (50090-7398-0)", "package_ndc": "50090-7398-0", "marketing_start_date": "20241023"}, {"sample": false, "description": "12 CAPSULE in 1 BOTTLE (50090-7398-3)", "package_ndc": "50090-7398-3", "marketing_start_date": "20241023"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (50090-7398-4)", "package_ndc": "50090-7398-4", "marketing_start_date": "20241023"}], "brand_name": "LOPERAMIDE HYDROCHLORIDE", "product_id": "50090-7398_fdda3cf0-8782-474c-95a7-5990383112f3", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "50090-7398", "generic_name": "LOPERAMIDE HYDROCHLORIDE", "labeler_name": "A-S Medication Solutions", "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"}