MECLIZINE HYDROCHLORIDE

Orange BookUNIISPLATC R06AE55

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeR06AE55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133505030
14 TABLET in 1 BOTTLE (71335-0503-0)
ndc11
7133505031
90 TABLET in 1 BOTTLE (71335-0503-1)
ndc11
7133505032
30 TABLET in 1 BOTTLE (71335-0503-2)
ndc11
7133505033
25 TABLET in 1 BOTTLE (71335-0503-3)
ndc11
7133505034
20 TABLET in 1 BOTTLE (71335-0503-4)
ndc11
7133505035
40 TABLET in 1 BOTTLE (71335-0503-5)
ndc11
7133505036
60 TABLET in 1 BOTTLE (71335-0503-6)
ndc11
7133505037
120 TABLET in 1 BOTTLE (71335-0503-7)
ndc11
7133505038
10 TABLET in 1 BOTTLE (71335-0503-8)
ndc11
7133505039
100 TABLET in 1 BOTTLE (71335-0503-9)

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": "71335-0503_50bf2686-9e05-4ae8-a8ee-761bea6f68e6",
  "productndc": "71335-0503",
  "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

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