Meclizine Hydrochloride

Orange BookUNIISPLATC R06AE55

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC

CountryUS (United States)

ATC codeR06AE55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5374644101
100 TABLET in 1 BOTTLE (53746-441-01)
ndc11
5374644110
1000 TABLET in 1 BOTTLE (53746-441-10)

Annotations

UNII (FDA Substance ID)

HDP7W44CIO

MECLIZINE HYDROCHLORIDE

RxCUI 82041

Orange Book

A201451

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": "53746-441_d4732fb5-fb04-4933-8ecc-98ab55184b54",
  "productndc": "53746-441",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201451",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Feb 23, 2011"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Feb 23, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Feb 23, 2011"
      }
    ],
    "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": "ANDA201451",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Meclizine Hydrochloride",
  "start_marketing_date": "20220422",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code R06AE55.

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