meclizine hydrochloride

Generic: meclizine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine hydrochloride
Generic Name meclizine hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 12.5 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7375
Product ID 0904-7375_87ac0ee9-aa64-4037-a047-a6d3a81da8d2
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 09047375
Hyphenated Format 0904-7375

Supplemental Identifiers

RxCUI
995624 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
  • 12.5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7375-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7375-61 100 BLISTER PACK in 1 CARTON (0904-7375-61) / 1 TABLET in 1 BLISTER PACK

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": "87ac0ee9-aa64-4037-a047-a6d3a81da8d2", "openfda": {"unii": ["HDP7W44CIO"], "rxcui": ["995624", "995666"], "spl_set_id": ["f99f13ab-33c0-4304-8dc5-3a75f3909377"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7375-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7375-61", "marketing_start_date": "20230718"}], "brand_name": "Meclizine Hydrochloride", "product_id": "0904-7375_87ac0ee9-aa64-4037-a047-a6d3a81da8d2", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "0904-7375", "generic_name": "Meclizine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "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"}