loperamide hydrochloride

Generic: loperamide hcl

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hcl
Labeler major pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loperamide hydrochloride 1 mg/7.5mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6836
Product ID 0904-6836_82067b3e-6f6d-4cd0-9bf7-bfbe3eab10e6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091292
Listing Expiration 2027-12-31
Marketing Start 2018-11-29

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046836
Hyphenated Format 0904-6836

Supplemental Identifiers

RxCUI
1250685
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 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 (0904-6836-20)
source: ndc

Packages (1)

0904-6836-20 120 mL in 1 BOTTLE (0904-6836-20)

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": "82067b3e-6f6d-4cd0-9bf7-bfbe3eab10e6", "openfda": {"unii": ["77TI35393C"], "rxcui": ["1250685"], "spl_set_id": ["cf5dc855-f0cc-4d7e-8d15-472f7e654409"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (0904-6836-20)", "package_ndc": "0904-6836-20", "marketing_start_date": "20181129"}], "brand_name": "loperamide hydrochloride", "product_id": "0904-6836_82067b3e-6f6d-4cd0-9bf7-bfbe3eab10e6", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0904-6836", "generic_name": "loperamide HCl", "labeler_name": "Major Pharmaceuticals", "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": "20181129", "listing_expiration_date": "20271231"}