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United States · US · US:83634-779_d6819f4b-aff3-476c-9cb3-b20bd518dd99

Metoclopramide

Orange BookUNIISPLATC A03FA01

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

Identification

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

Packs · 1

  • ndc11
    8363477902
    25 VIAL, SINGLE-DOSE in 1 CARTON (83634-779-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-779-41)

Annotations

UNII (FDA Substance ID)
W1792A2RVD
METOCLOPRAMIDE HYDROCHLORIDE
RxCUI 267036
Orange Book
A204756
AP
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": "83634-779_d6819f4b-aff3-476c-9cb3-b20bd518dd99",
  "productndc": "83634-779",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "204756",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/ML",
        "product_no": "001",
        "approval_date": "Dec 20, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METOCLOPRAMIDE HYDROCHLORIDE",
  "proprietary_name": "Metoclopramide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA204756",
  "marketing_category": "ANDA",
  "nonproprietary_name": "metoclopramide hydrochloride",
  "start_marketing_date": "20240630",
  "active_numerator_strength": "5"
}

Related drugs

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