hydroxyzine pamoate

Generic: hydroxyzine pamoate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine pamoate
Generic Name hydroxyzine pamoate
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyzine pamoate 25 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7065
Product ID 0904-7065_52c2f407-7a34-4a45-88ab-d4db6e4dd4c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201507
Listing Expiration 2026-12-31
Marketing Start 2013-06-03

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047065
Hyphenated Format 0904-7065

Supplemental Identifiers

RxCUI
995253
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
  • 25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7065-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7065-61 100 BLISTER PACK in 1 CARTON (0904-7065-61) / 1 CAPSULE in 1 BLISTER PACK

Ingredients (1)

hydroxyzine pamoate (25 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": "52c2f407-7a34-4a45-88ab-d4db6e4dd4c1", "openfda": {"unii": ["M20215MUFR"], "rxcui": ["995253"], "spl_set_id": ["f28f2a1b-8d65-4646-bd99-6e77617f9e1f"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7065-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7065-61", "marketing_start_date": "20130603"}], "brand_name": "hydroxyzine pamoate", "product_id": "0904-7065_52c2f407-7a34-4a45-88ab-d4db6e4dd4c1", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0904-7065", "generic_name": "hydroxyzine pamoate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydroxyzine pamoate", "active_ingredients": [{"name": "HYDROXYZINE PAMOATE", "strength": "25 mg/1"}], "application_number": "ANDA201507", "marketing_category": "ANDA", "marketing_start_date": "20130603", "listing_expiration_date": "20261231"}