loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler northstar rx llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-328
Product ID 72603-328_858c2b62-98e6-46d7-9253-9b3a00040a4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218122
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603328
Hyphenated Format 72603-328

Supplemental Identifiers

RxCUI
978006
UPC
0372603328011
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 loperamide hydrochloride (source: ndc)
Generic Name loperamide hydrochloride (source: ndc)
Application Number ANDA218122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (72603-328-01)
  • 500 CAPSULE in 1 BOTTLE (72603-328-02)
source: ndc

Packages (2)

72603-328-01 100 CAPSULE in 1 BOTTLE (72603-328-01) 72603-328-02 500 CAPSULE in 1 BOTTLE (72603-328-02)

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

LOPERAMIDE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "858c2b62-98e6-46d7-9253-9b3a00040a4e", "openfda": {"upc": ["0372603328011"], "unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["858c2b62-98e6-46d7-9253-9b3a00040a4e"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (72603-328-01)", "package_ndc": "72603-328-01", "marketing_start_date": "20241201"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (72603-328-02)", "package_ndc": "72603-328-02", "marketing_start_date": "20241201"}], "brand_name": "LOPERAMIDE HYDROCHLORIDE", "product_id": "72603-328_858c2b62-98e6-46d7-9253-9b3a00040a4e", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "72603-328", "generic_name": "LOPERAMIDE HYDROCHLORIDE", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LOPERAMIDE HYDROCHLORIDE", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA218122", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}