loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3618
Product ID 68071-3618_200c6126-b08d-7aa4-e063-6394a90ab9db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218122
Listing Expiration 2026-12-31
Marketing Start 2023-09-05

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713618
Hyphenated Format 68071-3618

Supplemental Identifiers

RxCUI
978006
UPC
0368071361810
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 hydrochloride (source: ndc)
Application Number ANDA218122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 12 CAPSULE in 1 BOTTLE (68071-3618-1)
  • 20 CAPSULE in 1 BOTTLE (68071-3618-2)
source: ndc

Packages (2)

68071-3618-1 12 CAPSULE in 1 BOTTLE (68071-3618-1) 68071-3618-2 20 CAPSULE in 1 BOTTLE (68071-3618-2)

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": "200c6126-b08d-7aa4-e063-6394a90ab9db", "openfda": {"upc": ["0368071361810"], "unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["1adb7a28-9dc6-3f8b-e063-6394a90a9335"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "12 CAPSULE in 1 BOTTLE (68071-3618-1)", "package_ndc": "68071-3618-1", "marketing_start_date": "20240614"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (68071-3618-2)", "package_ndc": "68071-3618-2", "marketing_start_date": "20240614"}], "brand_name": "LOPERAMIDE HYDROCHLORIDE", "product_id": "68071-3618_200c6126-b08d-7aa4-e063-6394a90ab9db", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "68071-3618", "generic_name": "LOPERAMIDE HYDROCHLORIDE", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LOPERAMIDE HYDROCHLORIDE", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA218122", "marketing_category": "ANDA", "marketing_start_date": "20230905", "listing_expiration_date": "20261231"}