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United States · US · US:83980-010_045886c5-5926-4d9e-a13c-8b0efc188862

Metoclopramide

Orange BookUNIISPLATC A03FA01

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

Identification

ManufacturerIpca Laboratories Limited
CountryUS (United States)
ATC codeA03FA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    8398001001
    100 TABLET in 1 BOTTLE (83980-010-01)
  • ndc11
    8398001005
    500 TABLET in 1 BOTTLE (83980-010-05)
  • ndc11
    8398001010
    1000 TABLET in 1 BOTTLE (83980-010-10)
  • ndc11
    8398001013
    30 TABLET in 1 BOTTLE (83980-010-13)

Annotations

UNII (FDA Substance ID)
W1792A2RVD
METOCLOPRAMIDE HYDROCHLORIDE
RxCUI 267036
Orange Book
A078807
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": "83980-010_045886c5-5926-4d9e-a13c-8b0efc188862",
  "productndc": "83980-010",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078807",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Jun 12, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Jun 12, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METOCLOPRAMIDE HYDROCHLORIDE",
  "proprietary_name": "Metoclopramide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078807",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metoclopramide",
  "start_marketing_date": "20250109",
  "active_numerator_strength": "5"
}

Related drugs

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