meclizine hydrochloride

Generic: meclizine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

meclizine hydrochloride 12.5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-522
Product ID 50268-522_47e73600-a8db-31d6-e063-6294a90a47f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201451
Listing Expiration 2027-12-31
Marketing Start 2013-08-08

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268522
Hyphenated Format 50268-522

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 (source: ndc)
Application Number ANDA201451 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-522-15) / 1 TABLET in 1 BLISTER PACK (50268-522-11)
source: ndc

Packages (1)

50268-522-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-522-15) / 1 TABLET in 1 BLISTER PACK (50268-522-11)

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": "47e73600-a8db-31d6-e063-6294a90a47f3", "openfda": {"unii": ["HDP7W44CIO"], "rxcui": ["995624", "995666"], "spl_set_id": ["af5d0c9b-a997-8033-afca-3c04221f2e76"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-522-15)  / 1 TABLET in 1 BLISTER PACK (50268-522-11)", "package_ndc": "50268-522-15", "marketing_start_date": "20130808"}], "brand_name": "Meclizine Hydrochloride", "product_id": "50268-522_47e73600-a8db-31d6-e063-6294a90a47f3", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "50268-522", "generic_name": "Meclizine", "labeler_name": "AvPAK", "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": "20130808", "listing_expiration_date": "20271231"}