meclizine hydrochloride

Generic: meclizine hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine hydrochloride
Generic Name meclizine hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 12.5 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-441
Product ID 53746-441_2d2a3b72-dab2-4e9f-b223-d6b591e2ed0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201451
Listing Expiration 2026-12-31
Marketing Start 2022-04-22

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746441
Hyphenated Format 53746-441

Supplemental Identifiers

RxCUI
995624 995666
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 hydrochloride (source: ndc)
Generic Name meclizine hydrochloride (source: ndc)
Application Number ANDA201451 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-441-01)
  • 1000 TABLET in 1 BOTTLE (53746-441-10)
source: ndc

Packages (2)

53746-441-01 100 TABLET in 1 BOTTLE (53746-441-01) 53746-441-10 1000 TABLET in 1 BOTTLE (53746-441-10)

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": "2d2a3b72-dab2-4e9f-b223-d6b591e2ed0c", "openfda": {"unii": ["HDP7W44CIO"], "rxcui": ["995624", "995666"], "spl_set_id": ["ff719d9c-8d80-42db-97a5-022a75773623"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-441-01)", "package_ndc": "53746-441-01", "marketing_start_date": "20220422"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-441-10)", "package_ndc": "53746-441-10", "marketing_start_date": "20220422"}], "brand_name": "Meclizine Hydrochloride", "product_id": "53746-441_2d2a3b72-dab2-4e9f-b223-d6b591e2ed0c", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "53746-441", "generic_name": "Meclizine Hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Meclizine Hydrochloride", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA201451", "marketing_category": "ANDA", "marketing_start_date": "20220422", "listing_expiration_date": "20261231"}