loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: chain drug marketing association inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler chain drug marketing association inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Chain Drug Marketing Association Inc.

Identifiers & Regulatory

Product NDC 63868-338
Product ID 63868-338_0ea72333-af5b-8141-e063-6294a90afe55
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074091
Listing Expiration 2026-12-31
Marketing Start 1993-02-01

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63868338
Hyphenated Format 63868-338

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
  • 12 TABLET in 1 BLISTER PACK (63868-338-12)
  • 24 TABLET in 1 BLISTER PACK (63868-338-24)
  • 60 TABLET in 1 BOTTLE (63868-338-60)
source: ndc

Packages (3)

63868-338-12 12 TABLET in 1 BLISTER PACK (63868-338-12) 63868-338-24 24 TABLET in 1 BLISTER PACK (63868-338-24) 63868-338-60 60 TABLET in 1 BOTTLE (63868-338-60)

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": "0ea72333-af5b-8141-e063-6294a90afe55", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["237b845b-0f02-410d-9750-c95123e6142d"], "manufacturer_name": ["Chain Drug Marketing Association Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BLISTER PACK (63868-338-12)", "package_ndc": "63868-338-12", "marketing_start_date": "19930201"}, {"sample": false, "description": "24 TABLET in 1 BLISTER PACK (63868-338-24)", "package_ndc": "63868-338-24", "marketing_start_date": "19930201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63868-338-60)", "package_ndc": "63868-338-60", "marketing_start_date": "19930201"}], "brand_name": "Loperamide Hydrochloride", "product_id": "63868-338_0ea72333-af5b-8141-e063-6294a90afe55", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "63868-338", "generic_name": "Loperamide Hydrochloride", "labeler_name": "Chain Drug Marketing Association 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": "19930201", "listing_expiration_date": "20261231"}