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United States · US · US:70518-4541_4717fcb4-b7c0-f308-e063-6394a90a536e

Metoclopramide

Orange BookUNIISPLATC A03FA01

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeA03FA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051845410
    40 TABLET in 1 BOTTLE, PLASTIC (70518-4541-0)

Annotations

UNII (FDA Substance ID)
W1792A2RVD
METOCLOPRAMIDE HYDROCHLORIDE
RxCUI 267036
Orange Book
N017854
ABAB
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": "70518-4541_4717fcb4-b7c0-f308-e063-6394a90a536e",
  "productndc": "70518-4541",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "017854",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "May 5, 1987"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METOCLOPRAMIDE HYDROCHLORIDE",
  "proprietary_name": "Metoclopramide",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA017854",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Metoclopramide",
  "start_marketing_date": "20251223",
  "active_numerator_strength": "10"
}

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