anti-diarrheal

Generic: loperamide hydrochloride

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti-diarrheal
Generic Name loperamide hydrochloride
Labeler advanced rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-401
Product ID 80513-401_1f6363e2-256d-68c3-e063-6394a90ac6c1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076497
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80513401
Hyphenated Format 80513-401

Supplemental Identifiers

RxCUI
978010
UPC
0380513001030
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 hydrochloride (source: ndc)
Application Number ANDA076497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (80513-401-24) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

80513-401-24 4 BLISTER PACK in 1 CARTON (80513-401-24) / 6 TABLET 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": "1f6363e2-256d-68c3-e063-6394a90ac6c1", "openfda": {"upc": ["0380513001030"], "unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["287bd6d9-aa29-4f56-9c7f-5cbacbf62537"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (80513-401-24)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "80513-401-24", "marketing_start_date": "20240811"}], "brand_name": "Anti-Diarrheal", "product_id": "80513-401_1f6363e2-256d-68c3-e063-6394a90ac6c1", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "80513-401", "generic_name": "Loperamide Hydrochloride", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anti-Diarrheal", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA076497", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}