loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

loperamide hydrochloride 2 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-020
Product ID 43063-020_413648bd-6784-dfcf-e063-6294a90a7d88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073192
Listing Expiration 2026-12-31
Marketing Start 1993-05-01

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063020
Hyphenated Format 43063-020

Supplemental Identifiers

RxCUI
978006
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 ANDA073192 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 12 CAPSULE in 1 BOTTLE, PLASTIC (43063-020-12)
source: ndc

Packages (1)

43063-020-12 12 CAPSULE in 1 BOTTLE, PLASTIC (43063-020-12)

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": "413648bd-6784-dfcf-e063-6294a90a7d88", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["580e6cd4-3f05-4996-9dc3-c50d757ae210"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "12 CAPSULE in 1 BOTTLE, PLASTIC (43063-020-12)", "package_ndc": "43063-020-12", "marketing_start_date": "20081028"}], "brand_name": "Loperamide Hydrochloride", "product_id": "43063-020_413648bd-6784-dfcf-e063-6294a90a7d88", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "43063-020", "generic_name": "Loperamide Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA073192", "marketing_category": "ANDA", "marketing_start_date": "19930501", "listing_expiration_date": "20261231"}