hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 50 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1265
Product ID 70518-1265_48c3a5d9-f8d3-1f39-e063-6394a90aee14
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204279
Listing Expiration 2027-12-31
Marketing Start 2018-06-19

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181265
Hyphenated Format 70518-1265

Supplemental Identifiers

RxCUI
995281
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
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE, PLASTIC (70518-1265-1)
  • 100 POUCH in 1 BOX (70518-1265-2) / 1 TABLET in 1 POUCH (70518-1265-3)
  • 100 POUCH in 1 BOX (70518-1265-4) / 1 TABLET in 1 POUCH (70518-1265-5)
source: ndc

Packages (3)

70518-1265-1 60 TABLET in 1 BOTTLE, PLASTIC (70518-1265-1) 70518-1265-2 100 POUCH in 1 BOX (70518-1265-2) / 1 TABLET in 1 POUCH (70518-1265-3) 70518-1265-4 100 POUCH in 1 BOX (70518-1265-4) / 1 TABLET in 1 POUCH (70518-1265-5)

Ingredients (1)

hydroxyzine dihydrochloride (50 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": "48c3a5d9-f8d3-1f39-e063-6394a90aee14", "openfda": {"unii": ["76755771U3"], "rxcui": ["995281"], "spl_set_id": ["4c2c4d8e-c3d1-48c7-8f99-ffa159667465"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (70518-1265-1)", "package_ndc": "70518-1265-1", "marketing_start_date": "20221025"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-1265-2)  / 1 TABLET in 1 POUCH (70518-1265-3)", "package_ndc": "70518-1265-2", "marketing_start_date": "20251027"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-1265-4)  / 1 TABLET in 1 POUCH (70518-1265-5)", "package_ndc": "70518-1265-4", "marketing_start_date": "20260105"}], "brand_name": "Hydroxyzine hydrochloride", "product_id": "70518-1265_48c3a5d9-f8d3-1f39-e063-6394a90aee14", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "70518-1265", "generic_name": "Hydroxyzine hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA204279", "marketing_category": "ANDA", "marketing_start_date": "20180619", "listing_expiration_date": "20271231"}