meclizine hydrochloride

Generic: meclizine hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine hydrochloride
Generic Name meclizine hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 12.5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8633
Product ID 68788-8633_769c5aef-cef1-4cd7-a775-3facb91cc01f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA010721
Listing Expiration 2026-12-31
Marketing Start 2024-04-16

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888633
Hyphenated Format 68788-8633

Supplemental Identifiers

RxCUI
995624
UNII
HDP7W44CIO

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 hydrochloride (source: ndc)
Application Number NDA010721 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (68788-8633-1)
  • 30 TABLET in 1 BOTTLE (68788-8633-3)
source: ndc

Packages (2)

68788-8633-1 10 TABLET in 1 BOTTLE (68788-8633-1) 68788-8633-3 30 TABLET in 1 BOTTLE (68788-8633-3)

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": "769c5aef-cef1-4cd7-a775-3facb91cc01f", "openfda": {"unii": ["HDP7W44CIO"], "rxcui": ["995624"], "spl_set_id": ["d7d31433-8f39-4fe6-b542-1b4410122db7"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (68788-8633-1)", "package_ndc": "68788-8633-1", "marketing_start_date": "20240416"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8633-3)", "package_ndc": "68788-8633-3", "marketing_start_date": "20240416"}], "brand_name": "Meclizine Hydrochloride", "product_id": "68788-8633_769c5aef-cef1-4cd7-a775-3facb91cc01f", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "68788-8633", "generic_name": "Meclizine Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Meclizine Hydrochloride", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "NDA010721", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240416", "listing_expiration_date": "20261231"}