meclizine

Generic: meclizine hcl 12.5 mg

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine
Generic Name meclizine hcl 12.5 mg
Labeler rugby laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 12.5 mg/1

Manufacturer
RUGBY LABORATORIES

Identifiers & Regulatory

Product NDC 0536-1297
Product ID 0536-1297_e35b2d6b-c702-4a55-a4bb-929b8a40012f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M009
Listing Expiration 2026-12-31
Marketing Start 2020-05-21

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05361297
Hyphenated Format 0536-1297

Supplemental Identifiers

RxCUI
995624
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 (source: ndc)
Generic Name meclizine hcl 12.5 mg (source: ndc)
Application Number M009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0536-1297-01)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0536-1297-10)
source: ndc

Packages (2)

0536-1297-01 100 TABLET in 1 BOTTLE, PLASTIC (0536-1297-01) 0536-1297-10 1000 TABLET in 1 BOTTLE, PLASTIC (0536-1297-10)

Ingredients (1)

meclizine hydrochloride (12.5 mg/1)

Linked Drug Pages (1)

MECLIZINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e35b2d6b-c702-4a55-a4bb-929b8a40012f", "openfda": {"unii": ["HDP7W44CIO"], "rxcui": ["995624"], "spl_set_id": ["8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35"], "manufacturer_name": ["RUGBY LABORATORIES"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0536-1297-01)", "package_ndc": "0536-1297-01", "marketing_start_date": "20200521"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0536-1297-10)", "package_ndc": "0536-1297-10", "marketing_start_date": "20200521"}], "brand_name": "MECLIZINE", "product_id": "0536-1297_e35b2d6b-c702-4a55-a4bb-929b8a40012f", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "0536-1297", "generic_name": "Meclizine HCl 12.5 mg", "labeler_name": "RUGBY LABORATORIES", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MECLIZINE", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "M009", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200521", "listing_expiration_date": "20261231"}