loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

loperamide hydrochloride 2 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7472
Product ID 0904-7472_c42d8eae-ae20-496d-b6a5-d58325ecfc7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218122
Listing Expiration 2026-12-31
Marketing Start 2024-12-20

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047472
Hyphenated Format 0904-7472

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
  • 100 BLISTER PACK in 1 CARTON (0904-7472-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7472-61 100 BLISTER PACK in 1 CARTON (0904-7472-61) / 1 CAPSULE in 1 BLISTER PACK

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": "c42d8eae-ae20-496d-b6a5-d58325ecfc7b", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["1be585e2-ef49-4210-8a2d-22a326e4cc1b"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7472-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7472-61", "marketing_start_date": "20241220"}], "brand_name": "LOPERAMIDE HYDROCHLORIDE", "product_id": "0904-7472_c42d8eae-ae20-496d-b6a5-d58325ecfc7b", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0904-7472", "generic_name": "LOPERAMIDE HYDROCHLORIDE", "labeler_name": "Major Pharmaceuticals", "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": "20241220", "listing_expiration_date": "20261231"}