topcare loperamide hydrochloride

Generic: loperamide hcl

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare loperamide hydrochloride
Generic Name loperamide hcl
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loperamide hydrochloride 1 mg/7.5mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-583
Product ID 36800-583_dc29e904-1358-4d41-8eed-d83136200862
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091292
Listing Expiration 2026-12-31
Marketing Start 2018-09-12

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800583
Hyphenated Format 36800-583

Supplemental Identifiers

RxCUI
1250685
UPC
0036800367531
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 topcare 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 (36800-583-26)
  • 240 mL in 1 BOTTLE (36800-583-34)
source: ndc

Packages (2)

36800-583-26 120 mL in 1 BOTTLE (36800-583-26) 36800-583-34 240 mL in 1 BOTTLE (36800-583-34)

Ingredients (1)

loperamide hydrochloride (1 mg/7.5mL)

Linked Drug Pages (1)

topcare loperamide hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dc29e904-1358-4d41-8eed-d83136200862", "openfda": {"upc": ["0036800367531"], "unii": ["77TI35393C"], "rxcui": ["1250685"], "spl_set_id": ["1cd497b4-d97e-447a-9251-710d2fddbf23"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (36800-583-26)", "package_ndc": "36800-583-26", "marketing_start_date": "20180912"}, {"sample": false, "description": "240 mL in 1 BOTTLE (36800-583-34)", "package_ndc": "36800-583-34", "marketing_start_date": "20220916"}], "brand_name": "topcare loperamide hydrochloride", "product_id": "36800-583_dc29e904-1358-4d41-8eed-d83136200862", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "36800-583", "generic_name": "loperamide HCl", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare loperamide hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "1 mg/7.5mL"}], "application_number": "ANDA091292", "marketing_category": "ANDA", "marketing_start_date": "20180912", "listing_expiration_date": "20261231"}