Meclizine Hydrochloride

Orange BookUNIISPLATC R06AE55

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

Identification

ManufacturerEpic Pharma LLC

CountryUS (United States)

ATC codeR06AE55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4280601401
100 TABLET in 1 BOTTLE (42806-014-01)
ndc11
4280601410
1000 TABLET in 1 BOTTLE (42806-014-10)

Annotations

UNII (FDA Substance ID)

HDP7W44CIO

MECLIZINE HYDROCHLORIDE

RxCUI 82041

Orange Book

A200294

AAAA

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": "42806-014_42600718-075b-481b-8fec-cb6cbadab7de",
  "productndc": "42806-014",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "200294",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Apr 13, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Apr 13, 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": "ANDA200294",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Meclizine Hydrochloride",
  "start_marketing_date": "20120430",
  "active_numerator_strength": "25"
}

Related drugs

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