hydroxyzine pamoate

Generic: hydroxyzine pamoate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine pamoate
Generic Name hydroxyzine pamoate
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyzine pamoate 25 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-398
Product ID 50268-398_47e54668-1645-b614-e063-6294a90ad949
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040156
Listing Expiration 2027-12-31
Marketing Start 2021-04-14

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268398
Hyphenated Format 50268-398

Supplemental Identifiers

RxCUI
995253 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 ANDA040156 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-398-50) / 1 CAPSULE in 1 BLISTER PACK (50268-398-11)
source: ndc

Packages (1)

50268-398-50 50 BLISTER PACK in 1 BOX (50268-398-50) / 1 CAPSULE in 1 BLISTER PACK (50268-398-11)

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": "47e54668-1645-b614-e063-6294a90ad949", "openfda": {"unii": ["M20215MUFR"], "rxcui": ["995253", "995278"], "spl_set_id": ["bff08c15-89b1-00f7-e053-2995a90a2ad8"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-398-50)  / 1 CAPSULE in 1 BLISTER PACK (50268-398-11)", "package_ndc": "50268-398-50", "marketing_start_date": "20210414"}], "brand_name": "Hydroxyzine Pamoate", "product_id": "50268-398_47e54668-1645-b614-e063-6294a90ad949", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "50268-398", "generic_name": "Hydroxyzine Pamoate", "labeler_name": "AvPAK", "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": "20210414", "listing_expiration_date": "20271231"}