hydroxyzine pamoate

Generic: hydroxyzine pamoate

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine pamoate
Generic Name hydroxyzine pamoate
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyzine pamoate 50 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1804
Product ID 0115-1804_bfba144b-f9a0-46c4-b55c-fe452bcd9f57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040156
Listing Expiration 2026-12-31
Marketing Start 1996-06-15

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151804
Hyphenated Format 0115-1804

Supplemental Identifiers

RxCUI
995253 995278
UPC
0301151803015 0301151804012
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 ANDA040156 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-01)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-02)
source: ndc

Packages (2)

0115-1804-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-01) 0115-1804-02 500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-02)

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": "bfba144b-f9a0-46c4-b55c-fe452bcd9f57", "openfda": {"upc": ["0301151803015", "0301151804012"], "unii": ["M20215MUFR"], "rxcui": ["995253", "995278"], "spl_set_id": ["bc82aaaf-30c7-4afe-a908-d138ea1268ef"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-01)", "package_ndc": "0115-1804-01", "marketing_start_date": "19960615"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-02)", "package_ndc": "0115-1804-02", "marketing_start_date": "19960615"}], "brand_name": "Hydroxyzine Pamoate", "product_id": "0115-1804_bfba144b-f9a0-46c4-b55c-fe452bcd9f57", "dosage_form": "CAPSULE", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0115-1804", "generic_name": "Hydroxyzine Pamoate", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Pamoate", "active_ingredients": [{"name": "HYDROXYZINE PAMOATE", "strength": "50 mg/1"}], "application_number": "ANDA040156", "marketing_category": "ANDA", "marketing_start_date": "19960615", "listing_expiration_date": "20261231"}