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 55289-315
Product ID 55289-315_4199e187-f646-693a-e063-6294a90ae583
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 55289315
Hyphenated Format 55289-315

Supplemental Identifiers

RxCUI
978006
UPC
0355289315155
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
  • 6 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-06)
  • 8 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-08)
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-10)
  • 12 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-12)
  • 15 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-15)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-20)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-30)
source: ndc

Packages (7)

55289-315-06 6 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-06) 55289-315-08 8 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-08) 55289-315-10 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-10) 55289-315-12 12 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-12) 55289-315-15 15 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-15) 55289-315-20 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-20) 55289-315-30 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-30)

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": "4199e187-f646-693a-e063-6294a90ae583", "openfda": {"upc": ["0355289315155"], "unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["3310a3c2-389a-4b27-a478-67c905789854"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-06)", "package_ndc": "55289-315-06", "marketing_start_date": "20110923"}, {"sample": false, "description": "8 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-08)", "package_ndc": "55289-315-08", "marketing_start_date": "20110923"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-10)", "package_ndc": "55289-315-10", "marketing_start_date": "20110923"}, {"sample": false, "description": "12 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-12)", "package_ndc": "55289-315-12", "marketing_start_date": "20110923"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-15)", "package_ndc": "55289-315-15", "marketing_start_date": "20110923"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-20)", "package_ndc": "55289-315-20", "marketing_start_date": "20110923"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-30)", "package_ndc": "55289-315-30", "marketing_start_date": "20110923"}], "brand_name": "Loperamide Hydrochloride", "product_id": "55289-315_4199e187-f646-693a-e063-6294a90ae583", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "55289-315", "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"}