Back to search
🇺🇸

United States · US · US:0264-3183_19ddbcf7-2edf-449b-b49c-b96ddb82d6c2

Meropenem and Sodium Chloride

Orange BookUNIISPLATC J01DH02

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

Identification

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

Packs · 1

  • ndc11
    0264318311
    24 CONTAINER in 1 CASE (0264-3183-11) / 50 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)
FV9J3JU8B1
MEROPENEM
RxCUI 29561
Orange Book
N202106
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": "0264-3183_19ddbcf7-2edf-449b-b49c-b96ddb82d6c2",
  "productndc": "0264-3183",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "202106",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Apr 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1GM/VIAL",
        "product_no": "002",
        "approval_date": "Apr 30, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEROPENEM",
  "proprietary_name": "Meropenem and Sodium Chloride",
  "active_ingred_unit": "mg/50mL",
  "application_number": "NDA202106",
  "marketing_category": "NDA",
  "nonproprietary_name": "Meropenem and Sodium Chloride",
  "start_marketing_date": "20150430",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01DH02.

Access this data programmatically

Query Meropenem and Sodium Chloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.