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United States · US · US:76045-213_4a411ded-d608-41d3-bb26-67d5d5d3c9b5

Metoclopramide

Orange BookUNIISPLATC A03FA01

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeA03FA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7604521320
    24 BLISTER PACK in 1 CARTON (76045-213-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-213-00) / 2 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)
W1792A2RVD
METOCLOPRAMIDE HYDROCHLORIDE
RxCUI 267036
Orange Book
A091392
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": "INTRAMUSCULAR; INTRAVENOUS",
  "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": "76045-213_4a411ded-d608-41d3-bb26-67d5d5d3c9b5",
  "productndc": "76045-213",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "091392",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE/ML",
        "product_no": "001",
        "approval_date": "Apr 19, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METOCLOPRAMIDE HYDROCHLORIDE",
  "proprietary_name": "Metoclopramide",
  "active_ingred_unit": "mg/2mL",
  "application_number": "ANDA091392",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metoclopramide Hydrochloride",
  "start_marketing_date": "20130503",
  "active_numerator_strength": "10"
}

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