loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: advagen pharma ltd.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler advagen pharma ltd.,
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Advagen Pharma Ltd.,

Identifiers & Regulatory

Product NDC 72888-130
Product ID 72888-130_47a17dfd-6255-f6f5-e063-6294a90a5660
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216876
Listing Expiration 2027-12-31
Marketing Start 2023-01-26

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888130
Hyphenated Format 72888-130

Supplemental Identifiers

RxCUI
978006
UPC
0372888130019 0372888130057 0372888130309 0372888130002
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 ANDA216876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1000 CAPSULE in 1 BOTTLE (72888-130-00)
  • 100 CAPSULE in 1 BOTTLE (72888-130-01)
  • 500 CAPSULE in 1 BOTTLE (72888-130-05)
  • 30 CAPSULE in 1 BOTTLE (72888-130-30)
source: ndc

Packages (4)

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "47a17dfd-6255-f6f5-e063-6294a90a5660", "openfda": {"upc": ["0372888130019", "0372888130057", "0372888130309", "0372888130002"], "unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["03c907d5-87f8-47a6-9544-5a24f5272739"], "manufacturer_name": ["Advagen Pharma Ltd.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (72888-130-00)", "package_ndc": "72888-130-00", "marketing_start_date": "20230126"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (72888-130-01)", "package_ndc": "72888-130-01", "marketing_start_date": "20230126"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (72888-130-05)", "package_ndc": "72888-130-05", "marketing_start_date": "20230126"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72888-130-30)", "package_ndc": "72888-130-30", "marketing_start_date": "20230126"}], "brand_name": "Loperamide Hydrochloride", "product_id": "72888-130_47a17dfd-6255-f6f5-e063-6294a90a5660", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "72888-130", "generic_name": "Loperamide Hydrochloride", "labeler_name": "Advagen Pharma Ltd.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA216876", "marketing_category": "ANDA", "marketing_start_date": "20230126", "listing_expiration_date": "20271231"}