meclizine hydrochloride

Generic: meclizine hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine hydrochloride
Generic Name meclizine hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 12.5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-797
Product ID 76420-797_158f70ad-1608-c116-e063-6394a90a94c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA010721
Listing Expiration 2026-12-31
Marketing Start 2020-01-15

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420797
Hyphenated Format 76420-797

Supplemental Identifiers

RxCUI
995624 995666 995686
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
  • 100 TABLET in 1 BOTTLE (76420-797-01)
  • 30 TABLET in 1 BOTTLE (76420-797-30)
  • 60 TABLET in 1 BOTTLE (76420-797-60)
  • 90 TABLET in 1 BOTTLE (76420-797-90)
source: ndc

Packages (4)

76420-797-01 100 TABLET in 1 BOTTLE (76420-797-01) 76420-797-30 30 TABLET in 1 BOTTLE (76420-797-30) 76420-797-60 60 TABLET in 1 BOTTLE (76420-797-60) 76420-797-90 90 TABLET in 1 BOTTLE (76420-797-90)

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": "158f70ad-1608-c116-e063-6394a90a94c6", "openfda": {"unii": ["HDP7W44CIO"], "rxcui": ["995624", "995666", "995686"], "spl_set_id": ["e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-797-01)", "package_ndc": "76420-797-01", "marketing_start_date": "20240405"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-797-30)", "package_ndc": "76420-797-30", "marketing_start_date": "20240405"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-797-60)", "package_ndc": "76420-797-60", "marketing_start_date": "20240405"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-797-90)", "package_ndc": "76420-797-90", "marketing_start_date": "20240405"}], "brand_name": "Meclizine Hydrochloride", "product_id": "76420-797_158f70ad-1608-c116-e063-6394a90a94c6", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "76420-797", "generic_name": "Meclizine Hydrochloride", "labeler_name": "Asclemed USA, 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": "20200115", "listing_expiration_date": "20261231"}