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United States · US · US:0781-3098_43866db8-b8f2-8140-e063-6394a90a90db

MEROPENEM

Orange BookUNIISPLATC J01DH02

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ01DH02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0781309895
    10 VIAL in 1 CARTON (0781-3098-95) / 30 mL in 1 VIAL (0781-3098-94)
  • ndc11
    0781309896
    25 VIAL in 1 CARTON (0781-3098-96) / 30 mL in 1 VIAL (0781-3098-94)

Annotations

UNII (FDA Substance ID)
FV9J3JU8B1
MEROPENEM
RxCUI 29561
Orange Book
A206086
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FV9J3JU8B1",
    "rxcui": "29561",
    "inchikey": "CTUAQTBUVLKNDJ-OBZXMJSBSA-N",
    "display_name": "MEROPENEM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e8848f4a-bca9-4978-b0a1-38483fd4d639": {
      "match": "brand_token",
      "title": "MEROPENEM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]",
      "spl_version": "2",
      "published_date": "2026-04-30"
    }
  },
  "productid": "0781-3098_43866db8-b8f2-8140-e063-6394a90a90db",
  "productndc": "0781-3098",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206086",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Apr 19, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/VIAL",
        "product_no": "002",
        "approval_date": "Apr 19, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEROPENEM",
  "proprietary_name": "MEROPENEM",
  "active_ingred_unit": "g/30mL",
  "application_number": "ANDA206086",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MEROPENEM",
  "start_marketing_date": "20160829",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code J01DH02.

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