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 72789-216
Product ID 72789-216_3caab728-dec4-fe78-e063-6294a90a17ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088618
Listing Expiration 2026-12-31
Marketing Start 2012-10-09

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789216
Hyphenated Format 72789-216

Supplemental Identifiers

RxCUI
995258
UPC
0372789216904
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 ANDA088618 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-04)
  • 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-12)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-30)
  • 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-40)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-90)
source: ndc

Packages (7)

72789-216-04 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-04) 72789-216-12 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-12) 72789-216-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-20) 72789-216-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-30) 72789-216-40 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-40) 72789-216-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-60) 72789-216-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-90)

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": "3caab728-dec4-fe78-e063-6294a90a17ec", "openfda": {"upc": ["0372789216904"], "unii": ["76755771U3"], "rxcui": ["995258"], "spl_set_id": ["2b05bd0e-af57-4e74-92f8-a4311330142f"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-04)", "package_ndc": "72789-216-04", "marketing_start_date": "20230817"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-12)", "package_ndc": "72789-216-12", "marketing_start_date": "20220214"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-20)", "package_ndc": "72789-216-20", "marketing_start_date": "20220324"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-30)", "package_ndc": "72789-216-30", "marketing_start_date": "20211130"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-40)", "package_ndc": "72789-216-40", "marketing_start_date": "20211118"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-60)", "package_ndc": "72789-216-60", "marketing_start_date": "20220624"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-90)", "package_ndc": "72789-216-90", "marketing_start_date": "20211208"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "72789-216_3caab728-dec4-fe78-e063-6294a90a17ec", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "72789-216", "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": "ANDA088618", "marketing_category": "ANDA", "marketing_start_date": "20121009", "listing_expiration_date": "20261231"}