hydroxyzine pamoate

Generic: hydroxyzine pamoate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine pamoate
Generic Name hydroxyzine pamoate
Labeler chartwell rx, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyzine pamoate 50 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-817
Product ID 62135-817_459cbe6c-6bd5-a598-e063-6394a90ac077
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 62135817
Hyphenated Format 62135-817

Supplemental Identifiers

RxCUI
995253 995278
UPC
0362135817121 0362135816124
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
  • 50 mg/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE (62135-817-12)
source: ndc

Packages (1)

62135-817-12 120 CAPSULE in 1 BOTTLE (62135-817-12)

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": "459cbe6c-6bd5-a598-e063-6394a90ac077", "openfda": {"upc": ["0362135817121", "0362135816124"], "unii": ["M20215MUFR"], "rxcui": ["995253", "995278"], "spl_set_id": ["abe7280a-1f6a-404b-9874-7710121e2090"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (62135-817-12)", "package_ndc": "62135-817-12", "marketing_start_date": "20240206"}], "brand_name": "Hydroxyzine pamoate", "product_id": "62135-817_459cbe6c-6bd5-a598-e063-6394a90ac077", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "62135-817", "generic_name": "Hydroxyzine pamoate", "labeler_name": "Chartwell RX, 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": "20130603", "listing_expiration_date": "20261231"}