hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 25 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-518
Product ID 43063-518_4138e4f8-23cf-c563-e063-6294a90ad9bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040787
Listing Expiration 2026-12-31
Marketing Start 2012-07-24

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063518
Hyphenated Format 43063-518

Supplemental Identifiers

RxCUI
995258
UNII
76755771U3

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 hydrochloride (source: ndc)
Generic Name hydroxyzine hydrochloride (source: ndc)
Application Number ANDA040787 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-06)
  • 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-12)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-20)
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-30)
  • 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-40)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-90)
source: ndc

Packages (8)

43063-518-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-06) 43063-518-12 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-12) 43063-518-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-20) 43063-518-28 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-28) 43063-518-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-30) 43063-518-40 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-40) 43063-518-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-60) 43063-518-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-90)

Ingredients (1)

hydroxyzine dihydrochloride (25 mg/1)

Linked Drug Pages (1)

Hydroxyzine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4138e4f8-23cf-c563-e063-6294a90ad9bb", "openfda": {"unii": ["76755771U3"], "rxcui": ["995258"], "spl_set_id": ["24cb9c83-a7e4-4bae-997c-c3a87426f78c"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-06)", "package_ndc": "43063-518-06", "marketing_start_date": "20120724"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-12)", "package_ndc": "43063-518-12", "marketing_start_date": "20120724"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-20)", "package_ndc": "43063-518-20", "marketing_start_date": "20120724"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-28)", "package_ndc": "43063-518-28", "marketing_start_date": "20120724"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-30)", "package_ndc": "43063-518-30", "marketing_start_date": "20120724"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-40)", "package_ndc": "43063-518-40", "marketing_start_date": "20120724"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-60)", "package_ndc": "43063-518-60", "marketing_start_date": "20191218"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-90)", "package_ndc": "43063-518-90", "marketing_start_date": "20120724"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "43063-518_4138e4f8-23cf-c563-e063-6294a90ad9bb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "43063-518", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040787", "marketing_category": "ANDA", "marketing_start_date": "20120724", "listing_expiration_date": "20261231"}