imodium a-d

Generic: loperamide hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imodium a-d
Generic Name loperamide hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-317
Product ID 50580-317_3f75a619-8881-0bb3-e063-6394a90a1bcc
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075232
Listing Expiration 2026-12-31
Marketing Start 2015-07-13

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580317
Hyphenated Format 50580-317

Supplemental Identifiers

RxCUI
978010 978013
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 imodium a-d (source: ndc)
Generic Name loperamide hydrochloride (source: ndc)
Application Number ANDA075232 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (50580-317-01) / 6 TABLET, FILM COATED in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (50580-317-03) / 6 TABLET, FILM COATED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (50580-317-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (50580-317-12) / 6 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

50580-317-01 1 BLISTER PACK in 1 CARTON (50580-317-01) / 6 TABLET, FILM COATED in 1 BLISTER PACK 50580-317-03 4 BLISTER PACK in 1 CARTON (50580-317-03) / 6 TABLET, FILM COATED in 1 BLISTER PACK 50580-317-06 2 BLISTER PACK in 1 CARTON (50580-317-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK 50580-317-12 2 BLISTER PACK in 1 CARTON (50580-317-12) / 6 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Imodium A-D ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f75a619-8881-0bb3-e063-6394a90a1bcc", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978010", "978013"], "spl_set_id": ["01da76d0-1979-4c45-9d39-c72ae4e4ffe2"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50580-317-01)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-317-01", "marketing_start_date": "20150713"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (50580-317-03)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-317-03", "marketing_start_date": "20150713"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-317-06)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-317-06", "marketing_start_date": "20200210"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-317-12)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-317-12", "marketing_start_date": "20240129"}], "brand_name": "Imodium A-D", "product_id": "50580-317_3f75a619-8881-0bb3-e063-6394a90a1bcc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "50580-317", "generic_name": "Loperamide hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Imodium", "brand_name_suffix": "A-D", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA075232", "marketing_category": "ANDA", "marketing_start_date": "20150713", "listing_expiration_date": "20261231"}