hydroxyzine pamoate

Generic: hydroxyzine pamoate

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine pamoate
Generic Name hydroxyzine pamoate
Labeler northwind health company, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyzine pamoate 50 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-046
Product ID 82868-046_47a6efa2-c61a-654f-e063-6294a90af3d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201507
Listing Expiration 2027-12-31
Marketing Start 2024-02-19

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82868046
Hyphenated Format 82868-046

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
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (82868-046-30)
source: ndc

Packages (1)

82868-046-30 30 CAPSULE in 1 BOTTLE, PLASTIC (82868-046-30)

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": "47a6efa2-c61a-654f-e063-6294a90af3d2", "openfda": {"unii": ["M20215MUFR"], "rxcui": ["995278"], "spl_set_id": ["127617c2-9775-3859-e063-6394a90a77cd"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (82868-046-30)", "package_ndc": "82868-046-30", "marketing_start_date": "20240219"}], "brand_name": "hydroxyzine pamoate", "product_id": "82868-046_47a6efa2-c61a-654f-e063-6294a90af3d2", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "82868-046", "generic_name": "hydroxyzine pamoate", "labeler_name": "Northwind Health Company, LLC", "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": "20240219", "listing_expiration_date": "20271231"}