loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-648
Product ID 71610-648_6971060e-f7f3-4055-837d-9c5a16e8ff6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215001
Listing Expiration 2026-12-31
Marketing Start 2020-09-25

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610648
Hyphenated Format 71610-648

Supplemental Identifiers

RxCUI
978006
UNII
77TI35393C

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 ANDA215001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (71610-648-53)
  • 90 CAPSULE in 1 BOTTLE (71610-648-60)
source: ndc

Packages (2)

71610-648-53 60 CAPSULE in 1 BOTTLE (71610-648-53) 71610-648-60 90 CAPSULE in 1 BOTTLE (71610-648-60)

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": "6971060e-f7f3-4055-837d-9c5a16e8ff6d", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["4d69532c-c71a-4880-9f74-4b37d912cabd"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-648-53)", "package_ndc": "71610-648-53", "marketing_start_date": "20220502"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-648-60)", "package_ndc": "71610-648-60", "marketing_start_date": "20220502"}], "brand_name": "Loperamide Hydrochloride", "product_id": "71610-648_6971060e-f7f3-4055-837d-9c5a16e8ff6d", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "71610-648", "generic_name": "Loperamide Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA215001", "marketing_category": "ANDA", "marketing_start_date": "20200925", "listing_expiration_date": "20261231"}