MECLIZINE HYDROCHLORIDE

Orange BookUNIISPLATC R06AE55

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeR06AE55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5965180905
500 TABLET in 1 BOTTLE (59651-809-05)
ndc11
5965180990
90 TABLET in 1 BOTTLE (59651-809-90)

Annotations

UNII (FDA Substance ID)

HDP7W44CIO

MECLIZINE HYDROCHLORIDE

RxCUI 82041

Orange Book

A202640

AAAAAA

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "HDP7W44CIO",
    "rxcui": "82041",
    "inchikey": "KDLHYOMCWBWLMM-UHFFFAOYSA-N",
    "display_name": "MECLIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52ee9258-8311-e6bd-e063-6294a90a567f": {
      "match": "brand_token",
      "title": "MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "59651-809_beb3c7f2-c0f4-41d9-a903-63a6847e0997",
  "productndc": "59651-809",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202640",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Sep 17, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Sep 17, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Sep 17, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MECLIZINE HYDROCHLORIDE",
  "proprietary_name": "MECLIZINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202640",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MECLIZINE",
  "start_marketing_date": "20230914",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code R06AE55.

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