hydroxyzine pamoate

Generic: hydroxyzine pamoate

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

Drug Facts

Product Profile

Brand Name hydroxyzine pamoate
Generic Name hydroxyzine pamoate
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyzine pamoate 50 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8789
Product ID 68788-8789_bbbd36cb-bc02-495e-b06f-caede3705f97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201507
Listing Expiration 2027-12-31
Marketing Start 2024-12-16

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888789
Hyphenated Format 68788-8789

Supplemental Identifiers

RxCUI
995278
UNII
M20215MUFR

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 hydroxyzine pamoate (source: ndc)
Generic Name hydroxyzine pamoate (source: ndc)
Application Number ANDA201507 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 CONTAINER (68788-8789-3)
source: ndc

Packages (1)

68788-8789-3 30 CAPSULE in 1 CONTAINER (68788-8789-3)

Ingredients (1)

hydroxyzine pamoate (50 mg/1)

Linked Drug Pages (1)

hydroxyzine pamoate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bbbd36cb-bc02-495e-b06f-caede3705f97", "openfda": {"unii": ["M20215MUFR"], "rxcui": ["995278"], "spl_set_id": ["b903f7e1-250d-46d8-a1ec-3f1dabc597f1"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 CONTAINER (68788-8789-3)", "package_ndc": "68788-8789-3", "marketing_start_date": "20241216"}], "brand_name": "hydroxyzine pamoate", "product_id": "68788-8789_bbbd36cb-bc02-495e-b06f-caede3705f97", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "68788-8789", "generic_name": "hydroxyzine pamoate", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydroxyzine pamoate", "active_ingredients": [{"name": "HYDROXYZINE PAMOATE", "strength": "50 mg/1"}], "application_number": "ANDA201507", "marketing_category": "ANDA", "marketing_start_date": "20241216", "listing_expiration_date": "20271231"}