hydroxyzine pamoate

Generic: hydroxyzine pamoate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxyzine pamoate 50 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0185-0615
Product ID 0185-0615_c94e4245-cac4-4d59-b3a3-64a09b67c2e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086183
Marketing Start 1981-12-14
Marketing End 2026-05-31

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01850615
Hyphenated Format 0185-0615

Supplemental Identifiers

RxCUI
995253 995278
UPC
0301850613014 0301850674015
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 ANDA086183 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0185-0615-01)
  • 500 CAPSULE in 1 BOTTLE (0185-0615-05)
source: ndc

Packages (2)

0185-0615-01 100 CAPSULE in 1 BOTTLE (0185-0615-01) 0185-0615-05 500 CAPSULE in 1 BOTTLE (0185-0615-05)

Ingredients (1)

hydroxyzine pamoate (50 mg/1)

Linked Drug Pages (1)

hydroxyzine pamoate, Hydroxyzine pamoate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c94e4245-cac4-4d59-b3a3-64a09b67c2e9", "openfda": {"upc": ["0301850613014", "0301850674015"], "unii": ["M20215MUFR"], "rxcui": ["995253", "995278"], "spl_set_id": ["c38cfd32-2562-4d6c-8a2e-d9984c16d9eb"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0185-0615-01)", "package_ndc": "0185-0615-01", "marketing_end_date": "20260531", "marketing_start_date": "19811214"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (0185-0615-05)", "package_ndc": "0185-0615-05", "marketing_end_date": "20260531", "marketing_start_date": "19811214"}], "brand_name": "hydroxyzine pamoate", "product_id": "0185-0615_c94e4245-cac4-4d59-b3a3-64a09b67c2e9", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0185-0615", "generic_name": "hydroxyzine pamoate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydroxyzine pamoate", "active_ingredients": [{"name": "HYDROXYZINE PAMOATE", "strength": "50 mg/1"}], "application_number": "ANDA086183", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "19811214"}