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 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-963
Product ID 43063-963_415f3642-ef05-3671-e063-6294a90ab7a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040788
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 43063963
Hyphenated Format 43063-963

Supplemental Identifiers

RxCUI
995218 995258 995281
UPC
0343063962954 0343063963012
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 ANDA040788 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-963-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-963-95)
source: ndc

Packages (2)

43063-963-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-963-01) 43063-963-95 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-963-95)

Ingredients (1)

hydroxyzine dihydrochloride (50 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": "415f3642-ef05-3671-e063-6294a90ab7a7", "openfda": {"upc": ["0343063962954", "0343063963012"], "unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-963-01)", "package_ndc": "43063-963-01", "marketing_start_date": "20190401"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-963-95)", "package_ndc": "43063-963-95", "marketing_start_date": "20190401"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "43063-963_415f3642-ef05-3671-e063-6294a90ab7a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "43063-963", "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": "50 mg/1"}], "application_number": "ANDA040788", "marketing_category": "ANDA", "marketing_start_date": "20120724", "listing_expiration_date": "20261231"}