hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0268
Product ID 71335-0268_38b4b826-574c-41c4-b201-cb6536b70f6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204279
Listing Expiration 2026-12-31
Marketing Start 2014-08-20

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713350268
Hyphenated Format 71335-0268

Supplemental Identifiers

RxCUI
995218
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 ANDA204279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71335-0268-1)
  • 100 TABLET in 1 BOTTLE (71335-0268-2)
  • 20 TABLET in 1 BOTTLE (71335-0268-3)
  • 90 TABLET in 1 BOTTLE (71335-0268-4)
  • 15 TABLET in 1 BOTTLE (71335-0268-5)
  • 60 TABLET in 1 BOTTLE (71335-0268-6)
  • 120 TABLET in 1 BOTTLE (71335-0268-7)
  • 10 TABLET in 1 BOTTLE (71335-0268-8)
source: ndc

Packages (8)

71335-0268-1 30 TABLET in 1 BOTTLE (71335-0268-1) 71335-0268-2 100 TABLET in 1 BOTTLE (71335-0268-2) 71335-0268-3 20 TABLET in 1 BOTTLE (71335-0268-3) 71335-0268-4 90 TABLET in 1 BOTTLE (71335-0268-4) 71335-0268-5 15 TABLET in 1 BOTTLE (71335-0268-5) 71335-0268-6 60 TABLET in 1 BOTTLE (71335-0268-6) 71335-0268-7 120 TABLET in 1 BOTTLE (71335-0268-7) 71335-0268-8 10 TABLET in 1 BOTTLE (71335-0268-8)

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": "38b4b826-574c-41c4-b201-cb6536b70f6e", "openfda": {"unii": ["76755771U3"], "rxcui": ["995218"], "spl_set_id": ["2562692e-e9cc-4f81-bdc9-47b7d4233758"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-0268-1)", "package_ndc": "71335-0268-1", "marketing_start_date": "20180405"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-0268-2)", "package_ndc": "71335-0268-2", "marketing_start_date": "20220202"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71335-0268-3)", "package_ndc": "71335-0268-3", "marketing_start_date": "20210625"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-0268-4)", "package_ndc": "71335-0268-4", "marketing_start_date": "20180504"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (71335-0268-5)", "package_ndc": "71335-0268-5", "marketing_start_date": "20220202"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-0268-6)", "package_ndc": "71335-0268-6", "marketing_start_date": "20220202"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71335-0268-7)", "package_ndc": "71335-0268-7", "marketing_start_date": "20220202"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (71335-0268-8)", "package_ndc": "71335-0268-8", "marketing_start_date": "20180220"}], "brand_name": "Hydroxyzine hydrochloride", "product_id": "71335-0268_38b4b826-574c-41c4-b201-cb6536b70f6e", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "71335-0268", "generic_name": "Hydroxyzine hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA204279", "marketing_category": "ANDA", "marketing_start_date": "20140820", "listing_expiration_date": "20261231"}