anti diarrheal

Generic: loperamide hcl

Labeler: l. perrigo company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti diarrheal
Generic Name loperamide hcl
Labeler l. perrigo company
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
L. Perrigo Company

Identifiers & Regulatory

Product NDC 0113-2224
Product ID 0113-2224_e47631c6-5e8d-48ce-a5f3-4482e9a7463c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075232
Listing Expiration 2026-12-31
Marketing Start 2018-06-25

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01132224
Hyphenated Format 0113-2224

Supplemental Identifiers

RxCUI
978010
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 anti diarrheal (source: ndc)
Generic Name loperamide hcl (source: ndc)
Application Number ANDA075232 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 24 BLISTER PACK in 1 CARTON (0113-2224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 36 BLISTER PACK in 1 CARTON (0113-2224-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0113-2224-62 24 BLISTER PACK in 1 CARTON (0113-2224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0113-2224-68 36 BLISTER PACK in 1 CARTON (0113-2224-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

anti diarrheal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e47631c6-5e8d-48ce-a5f3-4482e9a7463c", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["e5c96703-1487-4943-9b16-fa6a05e6b02e"], "manufacturer_name": ["L. Perrigo Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (0113-2224-62)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0113-2224-62", "marketing_start_date": "20191217"}, {"sample": false, "description": "36 BLISTER PACK in 1 CARTON (0113-2224-68)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0113-2224-68", "marketing_start_date": "20180625"}], "brand_name": "anti diarrheal", "product_id": "0113-2224_e47631c6-5e8d-48ce-a5f3-4482e9a7463c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0113-2224", "generic_name": "Loperamide HCl", "labeler_name": "L. Perrigo Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "anti diarrheal", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA075232", "marketing_category": "ANDA", "marketing_start_date": "20180625", "listing_expiration_date": "20261231"}