loperamide hydrochloride

Generic: loperamide hcl

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hcl
Labeler preferred pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loperamide hydrochloride 1 mg/7.5mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7842
Product ID 68788-7842_5f21733b-73e8-42b7-91af-059e5667ef91
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091292
Listing Expiration 2026-12-31
Marketing Start 2021-01-19

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687887842
Hyphenated Format 68788-7842

Supplemental Identifiers

RxCUI
1250685
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 hcl (source: ndc)
Application Number ANDA091292 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/7.5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (68788-7842-1)
source: ndc

Packages (1)

68788-7842-1 120 mL in 1 BOTTLE (68788-7842-1)

Ingredients (1)

loperamide hydrochloride (1 mg/7.5mL)

Linked Drug Pages (1)

loperamide hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5f21733b-73e8-42b7-91af-059e5667ef91", "openfda": {"unii": ["77TI35393C"], "rxcui": ["1250685"], "spl_set_id": ["0b1f8d41-51b3-4362-8de7-46bca5caff12"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (68788-7842-1)", "package_ndc": "68788-7842-1", "marketing_start_date": "20210119"}], "brand_name": "loperamide hydrochloride", "product_id": "68788-7842_5f21733b-73e8-42b7-91af-059e5667ef91", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "68788-7842", "generic_name": "loperamide HCl", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "loperamide hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "1 mg/7.5mL"}], "application_number": "ANDA091292", "marketing_category": "ANDA", "marketing_start_date": "20210119", "listing_expiration_date": "20261231"}