hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: apozeal pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler apozeal pharmaceuticals inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/5mL

Manufacturer
APOZEAL PHARMACEUTICALS INC

Identifiers & Regulatory

Product NDC 83745-232
Product ID 83745-232_832542b8-0454-465e-a50d-a749dcd1a84d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210634
Listing Expiration 2027-12-31
Marketing Start 2024-07-16

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83745232
Hyphenated Format 83745-232

Supplemental Identifiers

RxCUI
995241
UPC
0383745232166
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 ANDA210634 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (83745-232-16)
source: ndc

Packages (1)

83745-232-16 473 mL in 1 BOTTLE (83745-232-16)

Ingredients (1)

hydroxyzine dihydrochloride (10 mg/5mL)

Linked Drug Pages (1)

HYDROXYZINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "832542b8-0454-465e-a50d-a749dcd1a84d", "openfda": {"upc": ["0383745232166"], "unii": ["76755771U3"], "rxcui": ["995241"], "spl_set_id": ["87d4bbff-0498-4c26-86cb-7ce173afa0b6"], "manufacturer_name": ["APOZEAL PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (83745-232-16)", "package_ndc": "83745-232-16", "marketing_start_date": "20240716"}], "brand_name": "HYDROXYZINE HYDROCHLORIDE", "product_id": "83745-232_832542b8-0454-465e-a50d-a749dcd1a84d", "dosage_form": "SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "83745-232", "generic_name": "HYDROXYZINE HYDROCHLORIDE", "labeler_name": "APOZEAL PHARMACEUTICALS INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA210634", "marketing_category": "ANDA", "marketing_start_date": "20240716", "listing_expiration_date": "20271231"}