hydroxyzine pamoate

Generic: hydroxyzine pamoate

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

Drug Facts

Product Profile

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

hydroxyzine pamoate 25 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4954
Product ID 68071-4954_1b2e33e8-26b5-e5a0-e063-6294a90ae585
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 680714954
Hyphenated Format 68071-4954

Supplemental Identifiers

RxCUI
995253
UPC
0368071495430
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
  • 30 CAPSULE in 1 BOTTLE (68071-4954-3)
  • 90 CAPSULE in 1 BOTTLE (68071-4954-9)
source: ndc

Packages (2)

68071-4954-3 30 CAPSULE in 1 BOTTLE (68071-4954-3) 68071-4954-9 90 CAPSULE in 1 BOTTLE (68071-4954-9)

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": "1b2e33e8-26b5-e5a0-e063-6294a90ae585", "openfda": {"upc": ["0368071495430"], "unii": ["M20215MUFR"], "rxcui": ["995253"], "spl_set_id": ["8cb94f1d-1e45-531a-e053-2a95a90a1ba0"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68071-4954-3)", "package_ndc": "68071-4954-3", "marketing_start_date": "20190423"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68071-4954-9)", "package_ndc": "68071-4954-9", "marketing_start_date": "20230524"}], "brand_name": "hydroxyzine pamoate", "product_id": "68071-4954_1b2e33e8-26b5-e5a0-e063-6294a90ae585", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "68071-4954", "generic_name": "hydroxyzine pamoate", "labeler_name": "NuCare 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"}