hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler atlantic biologicals corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0507
Product ID 17856-0507_34f4870b-c857-c0d9-e063-6294a90a011a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201674
Listing Expiration 2026-12-31
Marketing Start 2013-08-21

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178560507
Hyphenated Format 17856-0507

Supplemental Identifiers

RxCUI
995241
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 ANDA201674 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0507-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0507-2)
source: ndc

Packages (1)

17856-0507-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0507-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0507-2)

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": "34f4870b-c857-c0d9-e063-6294a90a011a", "openfda": {"unii": ["76755771U3"], "rxcui": ["995241"], "spl_set_id": ["a2fbc502-6ca3-4304-9069-b7249c9d9489"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0507-1)  / 5 mL in 1 CUP, UNIT-DOSE (17856-0507-2)", "package_ndc": "17856-0507-1", "marketing_start_date": "20240508"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "17856-0507_34f4870b-c857-c0d9-e063-6294a90a011a", "dosage_form": "SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "17856-0507", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA201674", "marketing_category": "ANDA", "marketing_start_date": "20130821", "listing_expiration_date": "20261231"}