loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: allphamed pharbil arzneimittel gmbh
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler allphamed pharbil arzneimittel gmbh
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
allphamed Pharbil Arzneimittel GmbH

Identifiers & Regulatory

Product NDC 60468-005
Product ID 60468-005_f54d6351-da06-808b-e053-2a95a90ae4cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215001
Listing Expiration 2026-12-31
Marketing Start 2020-09-25

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60468005
Hyphenated Format 60468-005

Supplemental Identifiers

RxCUI
978006
UPC
0342799605036 0342799605012 0342799605029
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 ANDA215001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (60468-005-01)
  • 500 CAPSULE in 1 BOTTLE (60468-005-05)
  • 30 CAPSULE in 1 BOTTLE (60468-005-30)
source: ndc

Packages (3)

60468-005-01 100 CAPSULE in 1 BOTTLE (60468-005-01) 60468-005-05 500 CAPSULE in 1 BOTTLE (60468-005-05) 60468-005-30 30 CAPSULE in 1 BOTTLE (60468-005-30)

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": "f54d6351-da06-808b-e053-2a95a90ae4cb", "openfda": {"upc": ["0342799605036", "0342799605012", "0342799605029"], "unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["a8c8d1d2-a8c7-462a-b620-729a9baa93c4"], "manufacturer_name": ["allphamed Pharbil Arzneimittel GmbH"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (60468-005-01)", "package_ndc": "60468-005-01", "marketing_start_date": "20200925"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (60468-005-05)", "package_ndc": "60468-005-05", "marketing_start_date": "20200925"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (60468-005-30)", "package_ndc": "60468-005-30", "marketing_start_date": "20200925"}], "brand_name": "Loperamide Hydrochloride", "product_id": "60468-005_f54d6351-da06-808b-e053-2a95a90ae4cb", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "60468-005", "generic_name": "LOPERAMIDE HYDROCHLORIDE", "labeler_name": "allphamed Pharbil Arzneimittel GmbH", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA215001", "marketing_category": "ANDA", "marketing_start_date": "20200925", "listing_expiration_date": "20261231"}