meclizine

Generic: meclizine hcl 12.5 mg

Labeler: pharbest pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine
Generic Name meclizine hcl 12.5 mg
Labeler pharbest pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 12.5 mg/1

Manufacturer
Pharbest Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 16103-386
Product ID 16103-386_d7d81436-c338-4988-bf9e-a721e0cb8f91
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M009
Listing Expiration 2026-12-31
Marketing Start 2018-02-01

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16103386
Hyphenated Format 16103-386

Supplemental Identifiers

RxCUI
995624
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 (source: ndc)
Generic Name meclizine hcl 12.5 mg (source: ndc)
Application Number M009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (16103-386-08)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (16103-386-11)
source: ndc

Packages (2)

16103-386-08 100 TABLET in 1 BOTTLE, PLASTIC (16103-386-08) 16103-386-11 1000 TABLET in 1 BOTTLE, PLASTIC (16103-386-11)

Ingredients (1)

meclizine hydrochloride (12.5 mg/1)

Linked Drug Pages (1)

MECLIZINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d7d81436-c338-4988-bf9e-a721e0cb8f91", "openfda": {"unii": ["HDP7W44CIO"], "rxcui": ["995624"], "spl_set_id": ["8b3c9283-b618-4d57-9f15-7cf73e8737f5"], "manufacturer_name": ["Pharbest Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (16103-386-08)", "package_ndc": "16103-386-08", "marketing_start_date": "20180201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (16103-386-11)", "package_ndc": "16103-386-11", "marketing_start_date": "20180201"}], "brand_name": "MECLIZINE", "product_id": "16103-386_d7d81436-c338-4988-bf9e-a721e0cb8f91", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "16103-386", "generic_name": "Meclizine HCl 12.5 mg", "labeler_name": "Pharbest Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MECLIZINE", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "M009", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180201", "listing_expiration_date": "20261231"}