hydroxyzine pamoate

Generic: hydroxyzine pamoate

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

Drug Facts

Product Profile

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

hydroxyzine pamoate 50 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4463
Product ID 70518-4463_3e8556f2-6164-e13b-e063-6294a90afae3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201507
Listing Expiration 2026-12-31
Marketing Start 2025-08-30

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184463
Hyphenated Format 70518-4463

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
  • 21 CAPSULE in 1 BLISTER PACK (70518-4463-0)
  • 30 CAPSULE in 1 BLISTER PACK (70518-4463-1)
source: ndc

Packages (2)

70518-4463-0 21 CAPSULE in 1 BLISTER PACK (70518-4463-0) 70518-4463-1 30 CAPSULE in 1 BLISTER PACK (70518-4463-1)

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": "3e8556f2-6164-e13b-e063-6294a90afae3", "openfda": {"unii": ["M20215MUFR"], "rxcui": ["995278"], "spl_set_id": ["c0f7f48d-e39c-4981-9c0e-5c2eccaba424"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "21 CAPSULE in 1 BLISTER PACK (70518-4463-0)", "package_ndc": "70518-4463-0", "marketing_start_date": "20250830"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-4463-1)", "package_ndc": "70518-4463-1", "marketing_start_date": "20250911"}], "brand_name": "hydroxyzine pamoate", "product_id": "70518-4463_3e8556f2-6164-e13b-e063-6294a90afae3", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "70518-4463", "generic_name": "hydroxyzine pamoate", "labeler_name": "REMEDYREPACK 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": "20250830", "listing_expiration_date": "20261231"}