hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxyzine dihydrochloride 50 mg/25mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-050
Product ID 62135-050_25117412-3663-105d-e063-6394a90a0d64
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 62135050
Hyphenated Format 62135-050

Supplemental Identifiers

RxCUI
995241
UPC
0362135750473
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 (62135-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (62135-050-52)
source: ndc

Packages (1)

62135-050-24 2 TRAY in 1 BOX (62135-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (62135-050-52)

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": "25117412-3663-105d-e063-6394a90a0d64", "openfda": {"upc": ["0362135750473"], "unii": ["76755771U3"], "rxcui": ["995241"], "spl_set_id": ["53b2d731-f38a-47c0-9e5c-abd3b45e2fe1"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-050-24)  / 10 CUP in 1 TRAY / 25 mL in 1 CUP (62135-050-52)", "package_ndc": "62135-050-24", "marketing_start_date": "20240923"}], "brand_name": "HYDROXYZINE HYDROCHLORIDE", "product_id": "62135-050_25117412-3663-105d-e063-6394a90a0d64", "dosage_form": "SYRUP", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "62135-050", "generic_name": "HYDROXYZINE HYDROCHLORIDE", "labeler_name": "Chartwell 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"}