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 · 2

ndc11
0338035702
250 mL in 1 BAG (0338-0357-02)
ndc11
0338035703
500 mL in 1 BAG (0338-0357-03)

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": "0338-0357_3911fd42-2b73-4509-9c4c-92ceba4e6d34",
  "productndc": "0338-0357",
  "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": "20"
}

Related drugs

Other records sharing ATC code B05CX04.

Access this data programmatically

Query Osmitrol 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.

Get a free API key Read the API docs