Back to search
🇺🇸

United States · US · US:16571-663_2be27ea6-3d0a-4036-ab42-fea4720daa34

Meclizine Hydrochloride

Orange BookUNIISPLATC R06AE55

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeR06AE55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1657166301
    100 TABLET, CHEWABLE in 1 BOTTLE (16571-663-01)

Annotations

UNII (FDA Substance ID)
HDP7W44CIO
MECLIZINE HYDROCHLORIDE
RxCUI 82041
Orange Book
N010721
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": "16571-663_2be27ea6-3d0a-4036-ab42-fea4720daa34",
  "productndc": "16571-663",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "010721",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jan 20, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MECLIZINE HYDROCHLORIDE",
  "proprietary_name": "Meclizine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA010721",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Meclizine Hydrochloride",
  "start_marketing_date": "20200115",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code R06AE55.

Access this data programmatically

Query Meclizine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.