meclizine

Generic: meclizine hcl 12.5 mg

Labeler: advanced rx llc
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 advanced rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 12.5 mg/1

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-427
Product ID 80513-427_3e5a4128-ff9c-6f2b-e063-6394a90a42e6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M009
Listing Expiration 2026-12-31
Marketing Start 2025-09-01

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80513427
Hyphenated Format 80513-427

Supplemental Identifiers

RxCUI
995624
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 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
  • 200 TABLET in 1 BOTTLE, PLASTIC (80513-427-02)
source: ndc

Packages (1)

80513-427-02 200 TABLET in 1 BOTTLE, PLASTIC (80513-427-02)

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": "3e5a4128-ff9c-6f2b-e063-6394a90a42e6", "openfda": {"upc": ["0380513000316"], "unii": ["HDP7W44CIO"], "rxcui": ["995624"], "spl_set_id": ["032a89f2-17e7-45d2-94a1-cc7a601ebdee"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET in 1 BOTTLE, PLASTIC (80513-427-02)", "package_ndc": "80513-427-02", "marketing_start_date": "20250901"}], "brand_name": "MECLIZINE", "product_id": "80513-427_3e5a4128-ff9c-6f2b-e063-6394a90a42e6", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "80513-427", "generic_name": "Meclizine HCl 12.5 mg", "labeler_name": "Advanced Rx LLC", "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": "20250901", "listing_expiration_date": "20261231"}