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United States · US · US:81962-002_3877deca-080e-eeca-e063-6394a90a691a

Meropenem

Orange BookUNIISPLATC J01DH02

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

Identification

ManufacturerBROOKS STERISCIENCE LIMITED
CountryUS (United States)
ATC codeJ01DH02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8196200208
    6 INJECTION in 1 CARTON (81962-002-08)

Annotations

UNII (FDA Substance ID)
YOP6PX0BAO
MEROPENEM ANHYDROUS
RxCUI 1546029
Orange Book
A219084
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "YOP6PX0BAO",
    "rxcui": "1546029",
    "inchikey": "DMJNNHOOLUXYBV-PQTSNVLCSA-N",
    "display_name": "MEROPENEM ANHYDROUS",
    "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": "81962-002_3877deca-080e-eeca-e063-6394a90a691a",
  "productndc": "81962-002",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "219084",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/VIAL",
        "product_no": "001",
        "approval_date": "Jun 23, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEROPENEM ANHYDROUS",
  "proprietary_name": "Meropenem",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA219084",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Meropenem",
  "start_marketing_date": "20250627",
  "active_numerator_strength": "2"
}

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