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 70518-3413
Product ID 70518-3413_3a868d88-5537-65d5-e063-6394a90a8a9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215001
Listing Expiration 2026-12-31
Marketing Start 2022-04-17

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183413
Hyphenated Format 70518-3413

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 ANDA215001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 12 CAPSULE in 1 BOTTLE, PLASTIC (70518-3413-2)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (70518-3413-3)
source: ndc

Packages (2)

70518-3413-2 12 CAPSULE in 1 BOTTLE, PLASTIC (70518-3413-2) 70518-3413-3 20 CAPSULE in 1 BOTTLE, PLASTIC (70518-3413-3)

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": "3a868d88-5537-65d5-e063-6394a90a8a9e", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["71e6c12a-56bb-4655-ad0a-8ef3c3205249"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "12 CAPSULE in 1 BOTTLE, PLASTIC (70518-3413-2)", "package_ndc": "70518-3413-2", "marketing_start_date": "20250324"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (70518-3413-3)", "package_ndc": "70518-3413-3", "marketing_start_date": "20250324"}], "brand_name": "Loperamide Hydrochloride", "product_id": "70518-3413_3a868d88-5537-65d5-e063-6394a90a8a9e", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "70518-3413", "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": "ANDA215001", "marketing_category": "ANDA", "marketing_start_date": "20220417", "listing_expiration_date": "20261231"}