loperamide hydrochloride

Generic: loperamide hcl

Labeler: atlantic biologicals corp.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hcl
Labeler atlantic biologicals corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loperamide hydrochloride 1 mg/7.5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-6836
Product ID 17856-6836_34f553fc-3b63-65ee-e063-6294a90a3992
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091292
Listing Expiration 2026-12-31
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 178566836
Hyphenated Format 17856-6836

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
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-1) / 7.5 mL in 1 CUP, UNIT-DOSE (17856-6836-3)
  • 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-2) / 15 mL in 1 CUP, UNIT-DOSE (17856-6836-4)
source: ndc

Packages (2)

17856-6836-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-1) / 7.5 mL in 1 CUP, UNIT-DOSE (17856-6836-3) 17856-6836-2 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-2) / 15 mL in 1 CUP, UNIT-DOSE (17856-6836-4)

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": "34f553fc-3b63-65ee-e063-6294a90a3992", "openfda": {"unii": ["77TI35393C"], "rxcui": ["1250685"], "spl_set_id": ["7030f4ed-3cd1-428e-9cae-3b14933d41f5"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-1)  / 7.5 mL in 1 CUP, UNIT-DOSE (17856-6836-3)", "package_ndc": "17856-6836-1", "marketing_start_date": "20240422"}, {"sample": false, "description": "50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-2)  / 15 mL in 1 CUP, UNIT-DOSE (17856-6836-4)", "package_ndc": "17856-6836-2", "marketing_start_date": "20240422"}], "brand_name": "loperamide hydrochloride", "product_id": "17856-6836_34f553fc-3b63-65ee-e063-6294a90a3992", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "17856-6836", "generic_name": "loperamide HCl", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "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": "20261231"}