meclizine hydrochloride

Generic: meclizine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine hydrochloride
Generic Name meclizine
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 12.5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-807
Product ID 59651-807_beb3c7f2-c0f4-41d9-a903-63a6847e0997
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202640
Listing Expiration 2026-12-31
Marketing Start 2023-09-14

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651807
Hyphenated Format 59651-807

Supplemental Identifiers

RxCUI
995624 995666 995686
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 (source: ndc)
Application Number ANDA202640 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-807-01)
  • 1000 TABLET in 1 BOTTLE (59651-807-99)
source: ndc

Packages (2)

59651-807-01 100 TABLET in 1 BOTTLE (59651-807-01) 59651-807-99 1000 TABLET in 1 BOTTLE (59651-807-99)

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": "beb3c7f2-c0f4-41d9-a903-63a6847e0997", "openfda": {"unii": ["HDP7W44CIO"], "rxcui": ["995624", "995666", "995686"], "spl_set_id": ["beb3c7f2-c0f4-41d9-a903-63a6847e0997"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-807-01)", "package_ndc": "59651-807-01", "marketing_start_date": "20230914"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (59651-807-99)", "package_ndc": "59651-807-99", "marketing_start_date": "20230914"}], "brand_name": "MECLIZINE HYDROCHLORIDE", "product_id": "59651-807_beb3c7f2-c0f4-41d9-a903-63a6847e0997", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "59651-807", "generic_name": "MECLIZINE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MECLIZINE HYDROCHLORIDE", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA202640", "marketing_category": "ANDA", "marketing_start_date": "20230914", "listing_expiration_date": "20261231"}