imodium a-d

Generic: loperamide hydrochloride

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

Drug Facts

Product Profile

Brand Name imodium a-d
Generic Name loperamide hydrochloride
Labeler kenvue brands llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loperamide hydrochloride 1 mg/7.5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-134
Product ID 50580-134_3f73b325-ad6b-8e65-e063-6394a90a361e
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019487
Listing Expiration 2026-12-31
Marketing Start 2004-07-01

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580134
Hyphenated Format 50580-134

Supplemental Identifiers

RxCUI
1250685 1250693
UPC
0300450134080
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 NDA019487 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/7.5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (50580-134-04)
  • 240 mL in 1 BOTTLE (50580-134-08)
  • 120 mL in 1 BOTTLE (50580-134-44)
source: ndc

Packages (3)

50580-134-04 120 mL in 1 BOTTLE (50580-134-04) 50580-134-08 240 mL in 1 BOTTLE (50580-134-08) 50580-134-44 120 mL in 1 BOTTLE (50580-134-44)

Ingredients (1)

loperamide hydrochloride (1 mg/7.5mL)

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": "3f73b325-ad6b-8e65-e063-6394a90a361e", "openfda": {"upc": ["0300450134080"], "unii": ["77TI35393C"], "rxcui": ["1250685", "1250693"], "spl_set_id": ["76a976d5-8bee-4158-a94d-7fbfc5544fd4"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (50580-134-04)", "package_ndc": "50580-134-04", "marketing_start_date": "20040701"}, {"sample": false, "description": "240 mL in 1 BOTTLE (50580-134-08)", "package_ndc": "50580-134-08", "marketing_start_date": "20040701"}, {"sample": false, "description": "120 mL in 1 BOTTLE (50580-134-44)", "package_ndc": "50580-134-44", "marketing_start_date": "20040701"}], "brand_name": "Imodium A-D", "product_id": "50580-134_3f73b325-ad6b-8e65-e063-6394a90a361e", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "50580-134", "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": "1 mg/7.5mL"}], "application_number": "NDA019487", "marketing_category": "NDA", "marketing_start_date": "20040701", "listing_expiration_date": "20261231"}