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 71610-217
Product ID 71610-217_6b2afb94-dcdd-40b9-9d0b-eec36d08e42c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040156
Listing Expiration 2026-12-31
Marketing Start 1996-07-15

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610217
Hyphenated Format 71610-217

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 ANDA040156 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-30)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-53)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-60)
  • 120 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-70)
  • 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-80)
source: ndc

Packages (5)

71610-217-30 30 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-30) 71610-217-53 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-53) 71610-217-60 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-60) 71610-217-70 120 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-70) 71610-217-80 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-80)

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": "6b2afb94-dcdd-40b9-9d0b-eec36d08e42c", "openfda": {"unii": ["M20215MUFR"], "rxcui": ["995253"], "spl_set_id": ["d6a1df2e-c111-4ee7-9d56-469db19b7c60"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-30)", "package_ndc": "71610-217-30", "marketing_start_date": "20210909"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-53)", "package_ndc": "71610-217-53", "marketing_start_date": "20210909"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-60)", "package_ndc": "71610-217-60", "marketing_start_date": "20190107"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-70)", "package_ndc": "71610-217-70", "marketing_start_date": "20210909"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-80)", "package_ndc": "71610-217-80", "marketing_start_date": "20210909"}], "brand_name": "Hydroxyzine Pamoate", "product_id": "71610-217_6b2afb94-dcdd-40b9-9d0b-eec36d08e42c", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "71610-217", "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": "ANDA040156", "marketing_category": "ANDA", "marketing_start_date": "19960715", "listing_expiration_date": "20261231"}