Mannitol

Orange BookUNIISPLATC B05CX04

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeB05CX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0409403101
25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16)

Annotations

UNII (FDA Substance ID)

3OWL53L36A

MANNITOL

RxCUI 6628

Orange Book

N016269

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": "0409-4031_4092b5ac-45f3-4404-a790-c190eb8a3545",
  "productndc": "0409-4031",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "016269",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10GM/100ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15GM/100ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20GM/100ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "12.5GM/50ML",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "12.5GM/50ML",
        "product_no": "006",
        "approval_date": "Aug 25, 1994"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MANNITOL",
  "proprietary_name": "Mannitol",
  "active_ingred_unit": "g/50mL",
  "application_number": "NDA016269",
  "marketing_category": "NDA",
  "nonproprietary_name": "MANNITOL",
  "start_marketing_date": "20041130",
  "active_numerator_strength": "12.5"
}

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