Meropenem

Orange BookUNIISPLATC J01DH02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCivica, Inc.

CountryUS (United States)

ATC codeJ01DH02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7257241010
10 VIAL in 1 CARTON (72572-410-10) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

FV9J3JU8B1

MEROPENEM

RxCUI 29561

Orange Book

A216154

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": "72572-410_3e9af753-03b1-7206-e063-6294a90ad02d",
  "productndc": "72572-410",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216154",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Aug 18, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/VIAL",
        "product_no": "002",
        "approval_date": "Aug 18, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEROPENEM",
  "proprietary_name": "Meropenem",
  "active_ingred_unit": "g/20mL",
  "application_number": "ANDA216154",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Meropenem",
  "start_marketing_date": "20250908",
  "active_numerator_strength": "1"
}

Related drugs

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