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 CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-367
Product ID 50580-367_460d0a84-5c0c-b974-e063-6294a90ab761
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021855
Listing Expiration 2026-12-31
Marketing Start 2016-07-11

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580367
Hyphenated Format 50580-367

Supplemental Identifiers

RxCUI
978006 978009
UPC
0300450137241
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 NDA021855 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (50580-367-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (50580-367-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (2)

50580-367-01 1 BLISTER PACK in 1 CARTON (50580-367-01) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 50580-367-02 2 BLISTER PACK in 1 CARTON (50580-367-02) / 12 CAPSULE, LIQUID FILLED 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": "460d0a84-5c0c-b974-e063-6294a90ab761", "openfda": {"upc": ["0300450137241"], "unii": ["77TI35393C"], "rxcui": ["978006", "978009"], "spl_set_id": ["31bfcbb4-c58c-4edc-ac68-356a448b7507"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50580-367-01)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "50580-367-01", "marketing_start_date": "20160711"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-367-02)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "50580-367-02", "marketing_start_date": "20160711"}], "brand_name": "Imodium A-D", "product_id": "50580-367_460d0a84-5c0c-b974-e063-6294a90ab761", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "50580-367", "generic_name": "Loperamide Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Imodium A-D", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "NDA021855", "marketing_category": "NDA", "marketing_start_date": "20160711", "listing_expiration_date": "20261231"}