meclizine hydrochloride

Generic: meclizine hydrochloride

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine hydrochloride
Generic Name meclizine hydrochloride
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 25 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1162
Product ID 70710-1162_f084de6d-5e11-4c6e-8643-d0a4a48fc4da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213957
Listing Expiration 2026-12-31
Marketing Start 2020-10-29

Pharmacologic Class

Classes
antiemetic [epc] emesis suppression [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101162
Hyphenated Format 70710-1162

Supplemental Identifiers

RxCUI
995624 995666
UPC
0370710116118
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 hydrochloride (source: ndc)
Application Number ANDA213957 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70710-1162-0)
  • 100 TABLET in 1 BOTTLE (70710-1162-1)
  • 30 TABLET in 1 BOTTLE (70710-1162-3)
  • 10 BLISTER PACK in 1 CARTON (70710-1162-4) / 10 TABLET in 1 BLISTER PACK (70710-1162-2)
  • 90 TABLET in 1 BOTTLE (70710-1162-9)
source: ndc

Packages (5)

70710-1162-0 1000 TABLET in 1 BOTTLE (70710-1162-0) 70710-1162-1 100 TABLET in 1 BOTTLE (70710-1162-1) 70710-1162-3 30 TABLET in 1 BOTTLE (70710-1162-3) 70710-1162-4 10 BLISTER PACK in 1 CARTON (70710-1162-4) / 10 TABLET in 1 BLISTER PACK (70710-1162-2) 70710-1162-9 90 TABLET in 1 BOTTLE (70710-1162-9)

Ingredients (1)

meclizine hydrochloride (25 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": "f084de6d-5e11-4c6e-8643-d0a4a48fc4da", "openfda": {"upc": ["0370710116118"], "unii": ["HDP7W44CIO"], "rxcui": ["995624", "995666"], "spl_set_id": ["947a03c5-bca0-4d97-90b9-bcd6d6588273"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70710-1162-0)", "package_ndc": "70710-1162-0", "marketing_start_date": "20201029"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70710-1162-1)", "package_ndc": "70710-1162-1", "marketing_start_date": "20201029"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70710-1162-3)", "package_ndc": "70710-1162-3", "marketing_start_date": "20201029"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70710-1162-4)  / 10 TABLET in 1 BLISTER PACK (70710-1162-2)", "package_ndc": "70710-1162-4", "marketing_start_date": "20201029"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70710-1162-9)", "package_ndc": "70710-1162-9", "marketing_start_date": "20201029"}], "brand_name": "Meclizine Hydrochloride", "product_id": "70710-1162_f084de6d-5e11-4c6e-8643-d0a4a48fc4da", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "70710-1162", "generic_name": "Meclizine Hydrochloride", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Meclizine Hydrochloride", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA213957", "marketing_category": "ANDA", "marketing_start_date": "20201029", "listing_expiration_date": "20261231"}