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United States · US · US:0143-9398_0563c487-5b62-46fe-a7e3-8ade454f1f4f

ertapenem sodium

Orange BookUNIISPLATC J01DH03

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

Identification

ManufacturerHikma Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeJ01DH03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0143939810
    10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9398-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9398-01)

Annotations

UNII (FDA Substance ID)
2T90KE67L0
ERTAPENEM SODIUM
RxCUI 353107
Orange Book
A208790
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2T90KE67L0",
    "rxcui": "353107",
    "inchikey": "ZXNAQFZBWUNWJM-HRXMHBOMSA-M",
    "display_name": "ERTAPENEM SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "657855f2-7c92-4aa8-9c3d-51d08e56a09a": {
      "match": "brand_token",
      "title": "ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]",
      "spl_version": "13",
      "published_date": "2026-04-09"
    }
  },
  "productid": "0143-9398_0563c487-5b62-46fe-a7e3-8ade454f1f4f",
  "productndc": "0143-9398",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "208790",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Apr 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERTAPENEM SODIUM",
  "proprietary_name": "ertapenem sodium",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA208790",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ertapenem sodium",
  "start_marketing_date": "20210802",
  "active_numerator_strength": "1"
}

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