hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 25 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-080
Product ID 51655-080_46ddd139-5487-4c55-e063-6294a90a6f64
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204279
Listing Expiration 2027-12-31
Marketing Start 2020-12-10

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655080
Hyphenated Format 51655-080

Supplemental Identifiers

RxCUI
995258
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
  • 25 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE, PLASTIC (51655-080-20)
  • 60 TABLET in 1 BOTTLE, PLASTIC (51655-080-25)
  • 30 TABLET in 1 BOTTLE, PLASTIC (51655-080-52)
  • 10 TABLET in 1 BOTTLE, PLASTIC (51655-080-53)
source: ndc

Packages (4)

51655-080-20 20 TABLET in 1 BOTTLE, PLASTIC (51655-080-20) 51655-080-25 60 TABLET in 1 BOTTLE, PLASTIC (51655-080-25) 51655-080-52 30 TABLET in 1 BOTTLE, PLASTIC (51655-080-52) 51655-080-53 10 TABLET in 1 BOTTLE, PLASTIC (51655-080-53)

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": "46ddd139-5487-4c55-e063-6294a90a6f64", "openfda": {"unii": ["76755771U3"], "rxcui": ["995258"], "spl_set_id": ["c13455a3-3078-4fe1-e053-2a95a90adf8e"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (51655-080-20)", "package_ndc": "51655-080-20", "marketing_start_date": "20210420"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (51655-080-25)", "package_ndc": "51655-080-25", "marketing_start_date": "20220415"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (51655-080-52)", "package_ndc": "51655-080-52", "marketing_start_date": "20201210"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (51655-080-53)", "package_ndc": "51655-080-53", "marketing_start_date": "20230913"}], "brand_name": "Hydroxyzine hydrochloride", "product_id": "51655-080_46ddd139-5487-4c55-e063-6294a90a6f64", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "51655-080", "generic_name": "Hydroxyzine hydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA204279", "marketing_category": "ANDA", "marketing_start_date": "20201210", "listing_expiration_date": "20271231"}