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United States · US · US:43386-580_b5844be2-94b3-3e3f-e053-2995a90a6eb8

METOCLOPRAMIDE hydrochloride

Orange BookUNIISPLATC A03FA01

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

Identification

ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeA03FA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4338658031
    1 BLISTER PACK in 1 CARTON (43386-580-31) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
W1792A2RVD
METOCLOPRAMIDE HYDROCHLORIDE
RxCUI 267036
Orange Book
A202191
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "W1792A2RVD",
    "rxcui": "267036",
    "inchikey": "KJBLQGHJOCAOJP-UHFFFAOYSA-N",
    "display_name": "METOCLOPRAMIDE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5645a752-8868-4b51-8b59-48bb4276d763": {
      "match": "brand_token",
      "title": "METOCLOPRAMIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]",
      "spl_version": "8",
      "published_date": "2026-05-29"
    }
  },
  "productid": "43386-580_b5844be2-94b3-3e3f-e053-2995a90a6eb8",
  "productndc": "43386-580",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "202191",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 15, 2014"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Aug 15, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METOCLOPRAMIDE HYDROCHLORIDE",
  "proprietary_name": "METOCLOPRAMIDE hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202191",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metoclopramide Hydrochloride",
  "start_marketing_date": "20150406",
  "active_numerator_strength": "10"
}

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