MEROPENEM

Orange BookUNIISPLATC J01DH02

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

Identification

ManufacturerSavior Lifetec Corporation

CountryUS (United States)

ATC codeJ01DH02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4464703310
10 VIAL in 1 CARTON (44647-033-10) / 30 mL in 1 VIAL (44647-033-01)

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": "44647-033_4462e33b-7723-b7b4-e063-6294a90a981a",
  "productndc": "44647-033",
  "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": "20160419",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code J01DH02.

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