meclizine hydrochloride

Generic: meclizine hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meclizine hydrochloride
Generic Name meclizine hydrochloride
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

meclizine hydrochloride 12.5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1539
Product ID 70771-1539_83635604-72b7-4eb4-b8d9-5ae556041b4d
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 707711539
Hyphenated Format 70771-1539

Supplemental Identifiers

RxCUI
995624 995666
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
  • 12.5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1539-0)
  • 100 TABLET in 1 BOTTLE (70771-1539-1)
  • 30 TABLET in 1 BOTTLE (70771-1539-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1539-4) / 10 TABLET in 1 BLISTER PACK (70771-1539-2)
  • 90 TABLET in 1 BOTTLE (70771-1539-9)
source: ndc

Packages (5)

70771-1539-0 1000 TABLET in 1 BOTTLE (70771-1539-0) 70771-1539-1 100 TABLET in 1 BOTTLE (70771-1539-1) 70771-1539-3 30 TABLET in 1 BOTTLE (70771-1539-3) 70771-1539-4 10 BLISTER PACK in 1 CARTON (70771-1539-4) / 10 TABLET in 1 BLISTER PACK (70771-1539-2) 70771-1539-9 90 TABLET in 1 BOTTLE (70771-1539-9)

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": "83635604-72b7-4eb4-b8d9-5ae556041b4d", "openfda": {"unii": ["HDP7W44CIO"], "rxcui": ["995624", "995666"], "spl_set_id": ["cf157a71-f80a-4fb7-b892-7102b65a8ec0"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1539-0)", "package_ndc": "70771-1539-0", "marketing_start_date": "20201029"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1539-1)", "package_ndc": "70771-1539-1", "marketing_start_date": "20201029"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70771-1539-3)", "package_ndc": "70771-1539-3", "marketing_start_date": "20201029"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1539-4)  / 10 TABLET in 1 BLISTER PACK (70771-1539-2)", "package_ndc": "70771-1539-4", "marketing_start_date": "20201029"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70771-1539-9)", "package_ndc": "70771-1539-9", "marketing_start_date": "20201029"}], "brand_name": "Meclizine Hydrochloride", "product_id": "70771-1539_83635604-72b7-4eb4-b8d9-5ae556041b4d", "dosage_form": "TABLET", "pharm_class": ["Antiemetic [EPC]", "Emesis Suppression [PE]"], "product_ndc": "70771-1539", "generic_name": "Meclizine Hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Meclizine Hydrochloride", "active_ingredients": [{"name": "MECLIZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA213957", "marketing_category": "ANDA", "marketing_start_date": "20201029", "listing_expiration_date": "20261231"}