bonine

Generic: meclizine hydrochloride

Labeler: wellspring pharmaceutical corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name bonine
Generic Name meclizine hydrochloride
Labeler wellspring pharmaceutical corporation
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

meclizine hydrochloride 25 mg/1

Manufacturer
WellSpring Pharmaceutical Corporation

Identifiers & Regulatory

Product NDC 65197-296
Product ID 65197-296_7c66f984-240b-40dc-affd-9f1562f57c7c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M009
Marketing Start 2023-02-15
Marketing End 2026-12-31

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65197296
Hyphenated Format 65197-296

Supplemental Identifiers

RxCUI
995632 995634
UPC
0365197275120 0365197275083
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 bonine (source: ndc)
Generic Name meclizine hydrochloride (source: ndc)
Application Number M009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 BOX (65197-296-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK
  • 1 BOTTLE in 1 BOX (65197-296-12) / 12 TABLET, CHEWABLE in 1 BOTTLE
  • 2 BLISTER PACK in 1 BOX (65197-296-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (65197-296-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (4)

65197-296-08 1 BLISTER PACK in 1 BOX (65197-296-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK 65197-296-12 1 BOTTLE in 1 BOX (65197-296-12) / 12 TABLET, CHEWABLE in 1 BOTTLE 65197-296-16 2 BLISTER PACK in 1 BOX (65197-296-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK 65197-296-24 3 BLISTER PACK in 1 CARTON (65197-296-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

meclizine hydrochloride (25 mg/1)

Linked Drug Pages (1)

BONINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7c66f984-240b-40dc-affd-9f1562f57c7c", "openfda": {"upc": ["0365197275120", "0365197275083"], "unii": ["HDP7W44CIO"], "rxcui": ["995632", "995634"], "spl_set_id": ["ad3d66ca-a52c-43ba-b9e2-6269b8a413a9"], "manufacturer_name": ["WellSpring Pharmaceutical Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BOX (65197-296-08)  / 8 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "65197-296-08", "marketing_end_date": "20261231", "marketing_start_date": "20230215"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (65197-296-12)  / 12 TABLET, CHEWABLE in 1 BOTTLE", "package_ndc": "65197-296-12", "marketing_end_date": "20261031", "marketing_start_date": "20230215"}, {"sample": false, "description": "2 BLISTER PACK in 1 BOX (65197-296-16)  / 8 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "65197-296-16", "marketing_end_date": "20261231", "marketing_start_date": "20230215"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65197-296-24)  / 8 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "65197-296-24", "marketing_end_date": "20261231", "marketing_start_date": "20230501"}], "brand_name": "BONINE", "product_id": "65197-296_7c66f984-240b-40dc-affd-9f1562f57c7c", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "65197-296", "generic_name": "meclizine hydrochloride", "labeler_name": "WellSpring Pharmaceutical Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BONINE", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M009", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20261231", "marketing_start_date": "20230215"}