loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: zee medical inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler zee medical inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Zee Medical Inc

Identifiers & Regulatory

Product NDC 35418-123
Product ID 35418-123_0ea718d4-6b2b-b9ee-e063-6294a90a8111
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074091
Listing Expiration 2026-12-31
Marketing Start 2014-01-16

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35418123
Hyphenated Format 35418-123

Supplemental Identifiers

RxCUI
978010
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 hydrochloride (source: ndc)
Application Number ANDA074091 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (35418-123-12) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

35418-123-12 2 BLISTER PACK in 1 CARTON (35418-123-12) / 6 TABLET in 1 BLISTER PACK

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Loperamide Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0ea718d4-6b2b-b9ee-e063-6294a90a8111", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["07e1f89c-5bf6-4539-848a-4435e7deb0d2"], "manufacturer_name": ["Zee Medical Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (35418-123-12)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "35418-123-12", "marketing_start_date": "20140116"}], "brand_name": "Loperamide Hydrochloride", "product_id": "35418-123_0ea718d4-6b2b-b9ee-e063-6294a90a8111", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "35418-123", "generic_name": "Loperamide Hydrochloride", "labeler_name": "Zee Medical Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA074091", "marketing_category": "ANDA", "marketing_start_date": "20140116", "listing_expiration_date": "20261231"}