Meclizine Hydrochloride

Orange BookUNIISPLATC R06AE55

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC codeR06AE55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7071011610
1000 TABLET in 1 BOTTLE (70710-1161-0)
ndc11
7071011611
100 TABLET in 1 BOTTLE (70710-1161-1)
ndc11
7071011613
30 TABLET in 1 BOTTLE (70710-1161-3)
ndc11
7071011614
10 BLISTER PACK in 1 CARTON (70710-1161-4) / 10 TABLET in 1 BLISTER PACK (70710-1161-2)
ndc11
7071011619
90 TABLET in 1 BOTTLE (70710-1161-9)

Annotations

UNII (FDA Substance ID)

HDP7W44CIO

MECLIZINE HYDROCHLORIDE

RxCUI 82041

Orange Book

A213957

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": "70710-1161_f084de6d-5e11-4c6e-8643-d0a4a48fc4da",
  "productndc": "70710-1161",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213957",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Jun 23, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jun 23, 2020"
      }
    ],
    "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": "ANDA213957",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Meclizine Hydrochloride",
  "start_marketing_date": "20201029",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code R06AE55.

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