MECLIZINE HYDROCHLORIDE

Orange BookUNIISPLATC R06AE55

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeR06AE55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6318799610
10 TABLET in 1 BOTTLE (63187-996-10)
ndc11
6318799620
20 TABLET in 1 BOTTLE (63187-996-20)
ndc11
6318799630
30 TABLET in 1 BOTTLE (63187-996-30)
ndc11
6318799660
60 TABLET in 1 BOTTLE (63187-996-60)
ndc11
6318799690
90 TABLET in 1 BOTTLE (63187-996-90)

Annotations

UNII (FDA Substance ID)

HDP7W44CIO

MECLIZINE HYDROCHLORIDE

RxCUI 82041

Orange Book

A040659

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": "63187-996_6d44d894-810c-4608-a503-0cc6ff1f965d",
  "productndc": "63187-996",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040659",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Jun 4, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jun 4, 2010"
      }
    ],
    "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": "ANDA040659",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Meclizine Hydrocloride",
  "start_marketing_date": "20100604",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code R06AE55.

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