hydroxyzine pamoate

Generic: hydroxyzine pamoate

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine pamoate
Generic Name hydroxyzine pamoate
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyzine pamoate 25 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 14539-674
Product ID 14539-674_843627c2-146c-4715-b5b5-8c5c80a8f615
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 14539674
Hyphenated Format 14539-674

Supplemental Identifiers

RxCUI
995253 995278
UNII
M20215MUFR

Packaging Origin

Original Packager
true

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 CAPSULE in 1 CONTAINER (14539-674-01)
  • 500 CAPSULE in 1 CONTAINER (14539-674-05)
source: ndc

Packages (2)

14539-674-01 100 CAPSULE in 1 CONTAINER (14539-674-01) 14539-674-05 500 CAPSULE in 1 CONTAINER (14539-674-05)

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": "843627c2-146c-4715-b5b5-8c5c80a8f615", "openfda": {"unii": ["M20215MUFR"], "rxcui": ["995253", "995278"], "spl_set_id": ["734d32c8-38d3-430f-a2b3-539e03a3687a"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 CONTAINER (14539-674-01)", "package_ndc": "14539-674-01", "marketing_start_date": "20190423"}, {"sample": false, "description": "500 CAPSULE in 1 CONTAINER (14539-674-05)", "package_ndc": "14539-674-05", "marketing_start_date": "20190423"}], "brand_name": "hydroxyzine pamoate", "product_id": "14539-674_843627c2-146c-4715-b5b5-8c5c80a8f615", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "14539-674", "generic_name": "hydroxyzine pamoate", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "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"}