RECARBRIO

Orange BookUNIISPLATC J01DH

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

Identification

ManufacturerMerck Sharp & Dohme LLC

CountryUS (United States)

ATC codeJ01DH

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0006385602
25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01)

Annotations

UNII (FDA Substance ID)

141A6AMN38

CILASTATIN

RxCUI 2540

Orange Book

N212819

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "141A6AMN38",
    "rxcui": "2540",
    "inchikey": "DHSUYTOATWAVLW-WFVMDLQDSA-N",
    "display_name": "CILASTATIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "be32f468-738b-40df-a425-591e12f65159": {
      "match": "brand_token",
      "title": "RECARBRIO (IMIPENEM ANHYDROUS, CILASTATIN, AND RELEBACTAM ANHYDROUS) INJECTION, POWDER, FOR SOLUTION [MERCK SHARP & DOHME LLC]",
      "spl_version": "11",
      "published_date": "2025-12-19"
    }
  },
  "productid": "0006-3856_11f74255-d000-4759-a561-136a5f13f667",
  "productndc": "0006-3856",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "212819",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL",
        "product_no": "001",
        "approval_date": "Jul 16, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CILASTATIN; IMIPENEM ANHYDROUS; RELEBACTAM ANHYDROUS",
  "proprietary_name": "RECARBRIO",
  "active_ingred_unit": "mg/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA212819",
  "marketing_category": "NDA",
  "nonproprietary_name": "imipenem anhydrous, cilastatin, and relebactam anhydrous",
  "start_marketing_date": "20200106",
  "active_numerator_strength": "500; 500; 250"
}

Related drugs

Other records sharing ATC code J01DH.

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