Mannitol

Orange BookUNIISPLATC B05CX04

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

Identification

ManufacturerB. Braun Medical Inc.

CountryUS (United States)

ATC codeB05CX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0264757810
24 CONTAINER in 1 CASE (0264-7578-10) / 500 mL in 1 CONTAINER
ndc11
0264757820
24 CONTAINER in 1 CASE (0264-7578-20) / 250 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

3OWL53L36A

MANNITOL

RxCUI 6628

Orange Book

N020006

APAPAPAP

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": "0264-7578_33171b62-3532-4eb1-b273-714d07b0e3f8",
  "productndc": "0264-7578",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020006",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML",
        "product_no": "001",
        "approval_date": "Jul 26, 1993"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10GM/100ML",
        "product_no": "002",
        "approval_date": "Jul 26, 1993"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "15GM/100ML",
        "product_no": "003",
        "approval_date": "Jul 26, 1993"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20GM/100ML",
        "product_no": "004",
        "approval_date": "Jul 26, 1993"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MANNITOL",
  "proprietary_name": "Mannitol",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA020006",
  "marketing_category": "NDA",
  "nonproprietary_name": "MANNITOL",
  "start_marketing_date": "19930726",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code B05CX04.

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