hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler northstar rxllc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 25 mg/1

Manufacturer
Northstar RxLLC

Identifiers & Regulatory

Product NDC 16714-082
Product ID 16714-082_1a8febc0-9d51-4026-8ea6-6cba69e841c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040840
Listing Expiration 2027-12-31
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 16714082
Hyphenated Format 16714-082

Supplemental Identifiers

RxCUI
995218 995258 995281
UPC
0316714081106 0316714082103 0316714083100
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 ANDA040840 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16714-082-10)
  • 500 TABLET in 1 BOTTLE (16714-082-11)
  • 1000 TABLET in 1 BOTTLE (16714-082-12)
source: ndc

Packages (3)

16714-082-10 100 TABLET in 1 BOTTLE (16714-082-10) 16714-082-11 500 TABLET in 1 BOTTLE (16714-082-11) 16714-082-12 1000 TABLET in 1 BOTTLE (16714-082-12)

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": "1a8febc0-9d51-4026-8ea6-6cba69e841c5", "openfda": {"upc": ["0316714081106", "0316714082103", "0316714083100"], "unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["8e5fce17-936e-46ea-a969-518c952c2091"], "manufacturer_name": ["Northstar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16714-082-10)", "package_ndc": "16714-082-10", "marketing_start_date": "20091111"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16714-082-11)", "package_ndc": "16714-082-11", "marketing_start_date": "20091111"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (16714-082-12)", "package_ndc": "16714-082-12", "marketing_start_date": "20091111"}], "brand_name": "HydrOXYzine Hydrochloride", "product_id": "16714-082_1a8febc0-9d51-4026-8ea6-6cba69e841c5", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "16714-082", "generic_name": "HydrOXYzine Hydrochloride", "labeler_name": "Northstar RxLLC", "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": "20271231"}