meclizine hydrochloride

Generic: meclizine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine hydrochloride
Generic Name meclizine
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 12.5 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-441
Product ID 65162-441_50a794d1-8c02-4419-a037-de9d3825d342
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201451
Listing Expiration 2026-12-31
Marketing Start 2010-02-12

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162441
Hyphenated Format 65162-441

Supplemental Identifiers

RxCUI
995624 995666 995686
UPC
0365162444032 0365162442038 0365162441031
UNII
HDP7W44CIO

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 meclizine hydrochloride (source: ndc)
Generic Name meclizine (source: ndc)
Application Number ANDA201451 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-441-03)
  • 100 TABLET in 1 BOTTLE (65162-441-10)
  • 1000 TABLET in 1 BOTTLE (65162-441-11)
  • 500 TABLET in 1 BOTTLE (65162-441-50)
  • 100 TABLET in 1 BLISTER PACK (65162-441-60)
source: ndc

Packages (5)

65162-441-03 30 TABLET in 1 BOTTLE (65162-441-03) 65162-441-10 100 TABLET in 1 BOTTLE (65162-441-10) 65162-441-11 1000 TABLET in 1 BOTTLE (65162-441-11) 65162-441-50 500 TABLET in 1 BOTTLE (65162-441-50) 65162-441-60 100 TABLET in 1 BLISTER PACK (65162-441-60)

Ingredients (1)

meclizine hydrochloride (12.5 mg/1)

Linked Drug Pages (1)

Meclizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "50a794d1-8c02-4419-a037-de9d3825d342", "openfda": {"upc": ["0365162444032", "0365162442038", "0365162441031"], "unii": ["HDP7W44CIO"], "rxcui": ["995624", "995666", "995686"], "spl_set_id": ["666dc4d8-7b16-4c3c-84e4-645548dbee68"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-441-03)", "package_ndc": "65162-441-03", "marketing_start_date": "20100212"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (65162-441-10)", "package_ndc": "65162-441-10", "marketing_start_date": "20100212"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-441-11)", "package_ndc": "65162-441-11", "marketing_start_date": "20100212"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-441-50)", "package_ndc": "65162-441-50", "marketing_start_date": "20100212"}, {"sample": false, "description": "100 TABLET in 1 BLISTER PACK (65162-441-60)", "package_ndc": "65162-441-60", "marketing_start_date": "20100212"}], "brand_name": "Meclizine Hydrochloride", "product_id": "65162-441_50a794d1-8c02-4419-a037-de9d3825d342", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "65162-441", "generic_name": "Meclizine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Meclizine Hydrochloride", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA201451", "marketing_category": "ANDA", "marketing_start_date": "20100212", "listing_expiration_date": "20261231"}