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United States · US · US:0006-3862_428f7828-6d1c-438b-a17d-b4af0700c740

EMEND

Orange BookSPL

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

Identification

ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0006386203
    1 KIT in 1 DOSE PACK (0006-3862-03) * 1 CAPSULE in 1 CAPSULE * 1 CAPSULE in 1 CAPSULE
  • ndc11
    0006386213
    1 KIT in 1 DOSE PACK (0006-3862-13) * 1 CAPSULE in 1 CAPSULE * 1 CAPSULE in 1 CAPSULE

Annotations

Orange Book
N021549
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "8d66803a-6811-4c29-9c57-e16acfa87f21": {
      "match": "brand_token",
      "title": "EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]",
      "spl_version": "20",
      "published_date": "2026-03-04"
    }
  },
  "productid": "0006-3862_428f7828-6d1c-438b-a17d-b4af0700c740",
  "productndc": "0006-3862",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021549",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "001",
        "approval_date": "Mar 26, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "002",
        "approval_date": "Mar 26, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Jun 30, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "EMEND",
  "active_ingred_unit": null,
  "application_number": "NDA021549",
  "marketing_category": "NDA",
  "nonproprietary_name": "aprepitant",
  "start_marketing_date": "20030326",
  "active_numerator_strength": null
}

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