meclizine

Generic: meclizine hydrochloride

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine
Generic Name meclizine hydrochloride
Labeler advanced rx llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

meclizine hydrochloride 25 mg/1

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-421
Product ID 80513-421_27e17bc9-1e66-cc1f-e063-6394a90a4dcb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M009
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80513421
Hyphenated Format 80513-421

Supplemental Identifiers

RxCUI
995632
UPC
0380513000316
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 hydrochloride (source: ndc)
Application Number M009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 200 TABLET, CHEWABLE in 1 BOTTLE (80513-421-02)
source: ndc

Packages (1)

80513-421-02 200 TABLET, CHEWABLE in 1 BOTTLE (80513-421-02)

Ingredients (1)

meclizine hydrochloride (25 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": "27e17bc9-1e66-cc1f-e063-6394a90a4dcb", "openfda": {"upc": ["0380513000316"], "unii": ["HDP7W44CIO"], "rxcui": ["995632"], "spl_set_id": ["b0a2a1f7-354e-48bd-9e98-9207bf9f53fd"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET, CHEWABLE in 1 BOTTLE (80513-421-02)", "package_ndc": "80513-421-02", "marketing_start_date": "20241201"}], "brand_name": "Meclizine", "product_id": "80513-421_27e17bc9-1e66-cc1f-e063-6394a90a4dcb", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "80513-421", "generic_name": "Meclizine Hydrochloride", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Meclizine", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M009", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}