hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: kvk-tech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler kvk-tech, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-010
Product ID 10702-010_eff46bea-a884-5878-e053-2a95a90ae664
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040786
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 10702010
Hyphenated Format 10702-010

Supplemental Identifiers

RxCUI
995218 995258 995281
UPC
0310702012103
UNII
76755771U3

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 hydrochloride (source: ndc)
Generic Name hydroxyzine hydrochloride (source: ndc)
Application Number ANDA040786 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (10702-010-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (10702-010-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (10702-010-50)
source: ndc

Packages (3)

10702-010-01 100 TABLET, FILM COATED in 1 BOTTLE (10702-010-01) 10702-010-10 1000 TABLET, FILM COATED in 1 BOTTLE (10702-010-10) 10702-010-50 500 TABLET, FILM COATED in 1 BOTTLE (10702-010-50)

Ingredients (1)

hydroxyzine dihydrochloride (10 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": "eff46bea-a884-5878-e053-2a95a90ae664", "openfda": {"upc": ["0310702012103"], "unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["adc4cb73-77c6-48ff-aaf2-b3568d53de1f"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (10702-010-01)", "package_ndc": "10702-010-01", "marketing_start_date": "20120724"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (10702-010-10)", "package_ndc": "10702-010-10", "marketing_start_date": "20120724"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (10702-010-50)", "package_ndc": "10702-010-50", "marketing_start_date": "20120724"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "10702-010_eff46bea-a884-5878-e053-2a95a90ae664", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "10702-010", "generic_name": "hydroxyzine hydrochloride", "labeler_name": "KVK-Tech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA040786", "marketing_category": "ANDA", "marketing_start_date": "20120724", "listing_expiration_date": "20261231"}