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 · 8

ndc11
7133501531
30 TABLET in 1 BOTTLE (71335-0153-1)
ndc11
7133501532
60 TABLET in 1 BOTTLE (71335-0153-2)
ndc11
7133501533
90 TABLET in 1 BOTTLE (71335-0153-3)
ndc11
7133501534
28 TABLET in 1 BOTTLE (71335-0153-4)
ndc11
7133501535
20 TABLET in 1 BOTTLE (71335-0153-5)
ndc11
7133501536
120 TABLET in 1 BOTTLE (71335-0153-6)
ndc11
7133501537
100 TABLET in 1 BOTTLE (71335-0153-7)
ndc11
7133501538
10 TABLET in 1 BOTTLE (71335-0153-8)

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": "71335-0153_8503f13b-f759-463b-9385-9f3e5c275499",
  "productndc": "71335-0153",
  "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 Hydrochloride",
  "start_marketing_date": "20100604",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code R06AE55.

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