hydroxyzine pamoate

Generic: hydroxyzine pamoate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine pamoate
Generic Name hydroxyzine pamoate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyzine pamoate 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-883
Product ID 71610-883_33d81d2f-6f2c-d96e-e063-6394a90a4106
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 71610883
Hyphenated Format 71610-883

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
  • 30 CAPSULE in 1 BOTTLE (71610-883-30)
  • 60 CAPSULE in 1 BOTTLE (71610-883-53)
  • 90 CAPSULE in 1 BOTTLE (71610-883-60)
  • 120 CAPSULE in 1 BOTTLE (71610-883-70)
  • 180 CAPSULE in 1 BOTTLE (71610-883-80)
source: ndc

Packages (5)

71610-883-30 30 CAPSULE in 1 BOTTLE (71610-883-30) 71610-883-53 60 CAPSULE in 1 BOTTLE (71610-883-53) 71610-883-60 90 CAPSULE in 1 BOTTLE (71610-883-60) 71610-883-70 120 CAPSULE in 1 BOTTLE (71610-883-70) 71610-883-80 180 CAPSULE in 1 BOTTLE (71610-883-80)

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": "33d81d2f-6f2c-d96e-e063-6394a90a4106", "openfda": {"unii": ["M20215MUFR"], "rxcui": ["995253"], "spl_set_id": ["308cd178-a9d2-3132-e063-6394a90a7357"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-883-30)", "package_ndc": "71610-883-30", "marketing_start_date": "20250425"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71610-883-53)", "package_ndc": "71610-883-53", "marketing_start_date": "20250425"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-883-60)", "package_ndc": "71610-883-60", "marketing_start_date": "20250313"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71610-883-70)", "package_ndc": "71610-883-70", "marketing_start_date": "20250425"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (71610-883-80)", "package_ndc": "71610-883-80", "marketing_start_date": "20250313"}], "brand_name": "hydroxyzine pamoate", "product_id": "71610-883_33d81d2f-6f2c-d96e-e063-6394a90a4106", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "71610-883", "generic_name": "hydroxyzine pamoate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}