hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 50 mg/25mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-050
Product ID 68999-050_4356ec2d-ecb8-1aed-e063-6394a90ad74e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087294
Listing Expiration 2026-12-31
Marketing Start 1982-04-12

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68999050
Hyphenated Format 68999-050

Supplemental Identifiers

RxCUI
995241
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 ANDA087294 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/25mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (68999-050-52)
source: ndc

Packages (1)

68999-050-24 2 TRAY in 1 BOX (68999-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (68999-050-52)

Ingredients (1)

hydroxyzine dihydrochloride (50 mg/25mL)

Linked Drug Pages (1)

HYDROXYZINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4356ec2d-ecb8-1aed-e063-6394a90ad74e", "openfda": {"unii": ["76755771U3"], "rxcui": ["995241"], "spl_set_id": ["0de7a377-7a8f-4119-b172-1eadb4b7e1be"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-050-24)  / 10 CUP in 1 TRAY / 25 mL in 1 CUP (68999-050-52)", "package_ndc": "68999-050-24", "marketing_start_date": "20251031"}], "brand_name": "HYDROXYZINE HYDROCHLORIDE", "product_id": "68999-050_4356ec2d-ecb8-1aed-e063-6394a90ad74e", "dosage_form": "SYRUP", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "68999-050", "generic_name": "HYDROXYZINE HYDROCHLORIDE", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/25mL"}], "application_number": "ANDA087294", "marketing_category": "ANDA", "marketing_start_date": "19820412", "listing_expiration_date": "20261231"}