loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler amerisource bergen
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Amerisource Bergen

Identifiers & Regulatory

Product NDC 46122-738
Product ID 46122-738_c627fa26-44ac-4ba9-bc90-454a0ad98871
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206548
Listing Expiration 2026-12-31
Marketing Start 2023-07-05

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46122738
Hyphenated Format 46122-738

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 ANDA206548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (46122-738-53) / 6 TABLET in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (46122-738-62) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

46122-738-53 2 BLISTER PACK in 1 CARTON (46122-738-53) / 6 TABLET in 1 BLISTER PACK 46122-738-62 4 BLISTER PACK in 1 CARTON (46122-738-62) / 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": "c627fa26-44ac-4ba9-bc90-454a0ad98871", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["6c15f077-9f90-4262-9c17-a1ac70e45f57"], "manufacturer_name": ["Amerisource Bergen"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (46122-738-53)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "46122-738-53", "marketing_start_date": "20230705"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (46122-738-62)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "46122-738-62", "marketing_start_date": "20230720"}], "brand_name": "Loperamide Hydrochloride", "product_id": "46122-738_c627fa26-44ac-4ba9-bc90-454a0ad98871", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "46122-738", "generic_name": "Loperamide Hydrochloride", "labeler_name": "Amerisource Bergen", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA206548", "marketing_category": "ANDA", "marketing_start_date": "20230705", "listing_expiration_date": "20261231"}