loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1921
Product ID 71335-1921_fc76e96e-9ce8-de0f-e053-6294a90a0eb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072741
Listing Expiration 2026-12-31
Marketing Start 1991-09-18

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713351921
Hyphenated Format 71335-1921

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 ANDA072741 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 50 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-0)
  • 15 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-1)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-2)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-3)
  • 12 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-4)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-5)
  • 24 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-6)
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-7)
  • 9 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-8)
  • 5 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-9)
source: ndc

Packages (10)

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": "fc76e96e-9ce8-de0f-e053-6294a90a0eb2", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["f092b8a5-80b0-40ba-af45-2ac9edaa7704"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "50 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-0)", "package_ndc": "71335-1921-0", "marketing_start_date": "20220503"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-1)", "package_ndc": "71335-1921-1", "marketing_start_date": "20210730"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-2)", "package_ndc": "71335-1921-2", "marketing_start_date": "20210830"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-3)", "package_ndc": "71335-1921-3", "marketing_start_date": "20210818"}, {"sample": false, "description": "12 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-4)", "package_ndc": "71335-1921-4", "marketing_start_date": "20210820"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-5)", "package_ndc": "71335-1921-5", "marketing_start_date": "20220503"}, {"sample": false, "description": "24 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-6)", "package_ndc": "71335-1921-6", "marketing_start_date": "20210730"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-7)", "package_ndc": "71335-1921-7", "marketing_start_date": "20220503"}, {"sample": false, "description": "9 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-8)", "package_ndc": "71335-1921-8", "marketing_start_date": "20210726"}, {"sample": false, "description": "5 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-9)", "package_ndc": "71335-1921-9", "marketing_start_date": "20220223"}], "brand_name": "Loperamide Hydrochloride", "product_id": "71335-1921_fc76e96e-9ce8-de0f-e053-6294a90a0eb2", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "71335-1921", "generic_name": "loperamide hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA072741", "marketing_category": "ANDA", "marketing_start_date": "19910918", "listing_expiration_date": "20261231"}