Osmitrol

Orange BookUNIISPLATC B05CX04

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

Identification

ManufacturerBaxter Healthcare Company

CountryUS (United States)

ATC codeB05CX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338035303
500 mL in 1 BAG (0338-0353-03)

Annotations

UNII (FDA Substance ID)

3OWL53L36A

MANNITOL

RxCUI 6628

Orange Book

N013684

APAPAPAPAPAPAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3OWL53L36A",
    "rxcui": "6628",
    "inchikey": "FBPFZTCFMRRESA-KVTDHHQDSA-N",
    "display_name": "MANNITOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "0d914965-7001-45cb-ba51-d7c5964b05bc": {
      "match": "brand_token",
      "title": "OSMITROL (MANNITOL) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]",
      "spl_version": "16",
      "published_date": "2025-08-18"
    }
  },
  "productid": "0338-0353_3911fd42-2b73-4509-9c4c-92ceba4e6d34",
  "productndc": "0338-0353",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "013684",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10GM/100ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20GM/100ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "15GM/100ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10GM/100ML",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20GM/100ML",
        "product_no": "007",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "15GM/100ML",
        "product_no": "008",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MANNITOL",
  "proprietary_name": "Osmitrol",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA013684",
  "marketing_category": "NDA",
  "nonproprietary_name": "Mannitol",
  "start_marketing_date": "19640608",
  "active_numerator_strength": "10"
}

Related drugs

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