meclizine hydrochloride

Generic: meclizine hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine hydrochloride
Generic Name meclizine hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 25 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-058
Product ID 82868-058_476cb2cb-26c4-af46-e063-6394a90a2915
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201451
Listing Expiration 2027-12-31
Marketing Start 2024-06-11

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82868058
Hyphenated Format 82868-058

Supplemental Identifiers

RxCUI
995666
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 ANDA201451 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE, PLASTIC (82868-058-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (82868-058-30)
source: ndc

Packages (2)

82868-058-20 20 TABLET in 1 BOTTLE, PLASTIC (82868-058-20) 82868-058-30 30 TABLET in 1 BOTTLE, PLASTIC (82868-058-30)

Ingredients (1)

meclizine hydrochloride (25 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": "476cb2cb-26c4-af46-e063-6394a90a2915", "openfda": {"unii": ["HDP7W44CIO"], "rxcui": ["995666"], "spl_set_id": ["1b541252-e8a7-b678-e063-6394a90a34dc"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (82868-058-20)", "package_ndc": "82868-058-20", "marketing_start_date": "20250627"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (82868-058-30)", "package_ndc": "82868-058-30", "marketing_start_date": "20240611"}], "brand_name": "Meclizine Hydrochloride", "product_id": "82868-058_476cb2cb-26c4-af46-e063-6394a90a2915", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "82868-058", "generic_name": "Meclizine Hydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Meclizine Hydrochloride", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA201451", "marketing_category": "ANDA", "marketing_start_date": "20240611", "listing_expiration_date": "20271231"}