hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 25 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3450
Product ID 68071-3450_2d674f1c-812e-5feb-e063-6294a90a2aeb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040840
Listing Expiration 2026-12-31
Marketing Start 2009-11-11

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713450
Hyphenated Format 68071-3450

Supplemental Identifiers

RxCUI
995258
UPC
0368071345049
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 ANDA040840 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE (68071-3450-4)
source: ndc

Packages (1)

68071-3450-4 4 TABLET in 1 BOTTLE (68071-3450-4)

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": "2d674f1c-812e-5feb-e063-6294a90a2aeb", "openfda": {"upc": ["0368071345049"], "unii": ["76755771U3"], "rxcui": ["995258"], "spl_set_id": ["ffd33207-3f35-3486-e053-6394a90ac0ae"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE (68071-3450-4)", "package_ndc": "68071-3450-4", "marketing_start_date": "20230706"}], "brand_name": "HydrOXYzine Hydrochloride", "product_id": "68071-3450_2d674f1c-812e-5feb-e063-6294a90a2aeb", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "68071-3450", "generic_name": "HydrOXYzine Hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HydrOXYzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040840", "marketing_category": "ANDA", "marketing_start_date": "20091111", "listing_expiration_date": "20261231"}