loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler remedyrepack inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4283
Product ID 70518-4283_401a05f7-7d16-93f5-e063-6294a90a3daa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218122
Listing Expiration 2026-12-31
Marketing Start 2025-02-10

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184283
Hyphenated Format 70518-4283

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
  • 30 CAPSULE in 1 BLISTER PACK (70518-4283-0)
  • 30 CAPSULE in 1 BLISTER PACK (70518-4283-1)
  • 15 CAPSULE in 1 BLISTER PACK (70518-4283-2)
  • 10 CAPSULE in 1 BLISTER PACK (70518-4283-3)
source: ndc

Packages (4)

70518-4283-0 30 CAPSULE in 1 BLISTER PACK (70518-4283-0) 70518-4283-1 30 CAPSULE in 1 BLISTER PACK (70518-4283-1) 70518-4283-2 15 CAPSULE in 1 BLISTER PACK (70518-4283-2) 70518-4283-3 10 CAPSULE in 1 BLISTER PACK (70518-4283-3)

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": "401a05f7-7d16-93f5-e063-6294a90a3daa", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["3fdfc0e5-56a2-48a0-8ee6-390a194a29f3"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-4283-0)", "package_ndc": "70518-4283-0", "marketing_start_date": "20250210"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-4283-1)", "package_ndc": "70518-4283-1", "marketing_start_date": "20250214"}, {"sample": false, "description": "15 CAPSULE in 1 BLISTER PACK (70518-4283-2)", "package_ndc": "70518-4283-2", "marketing_start_date": "20250401"}, {"sample": false, "description": "10 CAPSULE in 1 BLISTER PACK (70518-4283-3)", "package_ndc": "70518-4283-3", "marketing_start_date": "20250407"}], "brand_name": "LOPERAMIDE HYDROCHLORIDE", "product_id": "70518-4283_401a05f7-7d16-93f5-e063-6294a90a3daa", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "70518-4283", "generic_name": "LOPERAMIDE HYDROCHLORIDE", "labeler_name": "REMEDYREPACK INC.", "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": "20250210", "listing_expiration_date": "20261231"}