loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-0311
Product ID 0093-0311_863c19d4-c0cd-455e-9a93-5c5157762d02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073192
Listing Expiration 2026-12-31
Marketing Start 1993-05-01

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00930311
Hyphenated Format 0093-0311

Supplemental Identifiers

RxCUI
978006
UNII
77TI35393C

Packaging Origin

Original Packager
true

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 ANDA073192 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0093-0311-01)
  • 500 CAPSULE in 1 BOTTLE (0093-0311-05)
source: ndc

Packages (2)

0093-0311-01 100 CAPSULE in 1 BOTTLE (0093-0311-01) 0093-0311-05 500 CAPSULE in 1 BOTTLE (0093-0311-05)

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": "863c19d4-c0cd-455e-9a93-5c5157762d02", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["8bf47ac3-746f-47c3-82b2-32ac979ff963"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0093-0311-01)", "package_ndc": "0093-0311-01", "marketing_start_date": "19930501"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (0093-0311-05)", "package_ndc": "0093-0311-05", "marketing_start_date": "19930501"}], "brand_name": "Loperamide Hydrochloride", "product_id": "0093-0311_863c19d4-c0cd-455e-9a93-5c5157762d02", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0093-0311", "generic_name": "Loperamide Hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA073192", "marketing_category": "ANDA", "marketing_start_date": "19930501", "listing_expiration_date": "20261231"}