Mannitol

Orange BookUNIISPLATC B05CX04

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

Identification

ManufacturerICU Medical Inc.

CountryUS (United States)

ATC codeB05CX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0990771502
24 POUCH in 1 CASE (0990-7715-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0990-7715-12)
ndc11
0990771503
12 POUCH in 1 CASE (0990-7715-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0990-7715-13)

Annotations

UNII (FDA Substance ID)

3OWL53L36A

MANNITOL

RxCUI 6628

Orange Book

N019603

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": {
    "8ad3145e-00e7-4412-b9a5-06f00f264f30": {
      "match": "brand_token",
      "title": "MANNITOL INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "23",
      "published_date": "2026-04-23"
    }
  },
  "productid": "0990-7715_b0dfadd1-70b5-49f5-8b63-60d3b4e1cbf5",
  "productndc": "0990-7715",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019603",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML",
        "product_no": "001",
        "approval_date": "Jan 8, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10GM/100ML",
        "product_no": "002",
        "approval_date": "Jan 8, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15GM/100ML",
        "product_no": "003",
        "approval_date": "Jan 8, 1990"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20GM/100ML",
        "product_no": "004",
        "approval_date": "Jan 8, 1990"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MANNITOL",
  "proprietary_name": "Mannitol",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA019603",
  "marketing_category": "NDA",
  "nonproprietary_name": "MANNITOL",
  "start_marketing_date": "20190531",
  "active_numerator_strength": "20"
}

Related drugs

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