loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: precision dose, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler precision dose, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loperamide hydrochloride 1 mg/7.5mL

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-129
Product ID 68094-129_73a0214b-3f58-4357-ab53-314111602166
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091292
Listing Expiration 2026-12-31
Marketing Start 2020-05-18

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094129
Hyphenated Format 68094-129

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 hydrochloride (source: ndc)
Application Number ANDA091292 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/7.5mL
source: ndc
Packaging
  • 3 TRAY in 1 CASE (68094-129-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68094-129-59)
source: ndc

Packages (1)

68094-129-62 3 TRAY in 1 CASE (68094-129-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68094-129-59)

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": "73a0214b-3f58-4357-ab53-314111602166", "openfda": {"unii": ["77TI35393C"], "rxcui": ["1250685"], "spl_set_id": ["ae8237f0-95a6-4163-b476-25c0509ef151"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (68094-129-62)  / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68094-129-59)", "package_ndc": "68094-129-62", "marketing_start_date": "20200518"}], "brand_name": "Loperamide Hydrochloride", "product_id": "68094-129_73a0214b-3f58-4357-ab53-314111602166", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "68094-129", "generic_name": "Loperamide Hydrochloride", "labeler_name": "Precision Dose, 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": "20200518", "listing_expiration_date": "20261231"}