loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

loperamide hydrochloride 2 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-138
Product ID 72578-138_50a14097-cb3f-4064-97d8-2a662c5a4ad0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217471
Listing Expiration 2026-12-31
Marketing Start 2023-06-25

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578138
Hyphenated Format 72578-138

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 ANDA217471 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (72578-138-01)
  • 500 CAPSULE in 1 BOTTLE (72578-138-05)
  • 10 BLISTER PACK in 1 CARTON (72578-138-77) / 10 CAPSULE in 1 BLISTER PACK (72578-138-30)
source: ndc

Packages (3)

72578-138-01 100 CAPSULE in 1 BOTTLE (72578-138-01) 72578-138-05 500 CAPSULE in 1 BOTTLE (72578-138-05) 72578-138-77 10 BLISTER PACK in 1 CARTON (72578-138-77) / 10 CAPSULE in 1 BLISTER PACK (72578-138-30)

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": "50a14097-cb3f-4064-97d8-2a662c5a4ad0", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["330677ff-5426-40bd-af45-e3836cb77893"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (72578-138-01)", "package_ndc": "72578-138-01", "marketing_start_date": "20230625"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (72578-138-05)", "package_ndc": "72578-138-05", "marketing_start_date": "20230625"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (72578-138-77)  / 10 CAPSULE in 1 BLISTER PACK (72578-138-30)", "package_ndc": "72578-138-77", "marketing_start_date": "20230625"}], "brand_name": "Loperamide hydrochloride", "product_id": "72578-138_50a14097-cb3f-4064-97d8-2a662c5a4ad0", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "72578-138", "generic_name": "Loperamide hydrochloride", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA217471", "marketing_category": "ANDA", "marketing_start_date": "20230625", "listing_expiration_date": "20261231"}