mannitol

Generic: mannitol

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mannitol
Generic Name mannitol
Labeler henry schein, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mannitol 12.5 g/50mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9905
Product ID 0404-9905_f3bb5de6-286d-4efc-a55d-e0b65dc4b1c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016269
Listing Expiration 2026-12-31
Marketing Start 2022-01-12

Pharmacologic Class

Established (EPC)
osmotic diuretic [epc]
Mechanism of Action
osmotic activity [moa]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049905
Hyphenated Format 0404-9905

Supplemental Identifiers

RxCUI
311450
UNII
3OWL53L36A
NUI
N0000175359 N0000010288 N0000175810

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mannitol (source: ndc)
Generic Name mannitol (source: ndc)
Application Number NDA016269 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 12.5 g/50mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9905-50 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

mannitol (12.5 g/50mL)

Linked Drug Pages (1)

Mannitol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f3bb5de6-286d-4efc-a55d-e0b65dc4b1c2", "openfda": {"nui": ["N0000175359", "N0000010288", "N0000175810"], "unii": ["3OWL53L36A"], "rxcui": ["311450"], "spl_set_id": ["e2444db1-9dfe-451f-a33c-9b00786464d2"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Osmotic Diuretic [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9905-50", "marketing_start_date": "20220112"}], "brand_name": "Mannitol", "product_id": "0404-9905_f3bb5de6-286d-4efc-a55d-e0b65dc4b1c2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Increased Diuresis [PE]", "Osmotic Activity [MoA]", "Osmotic Diuretic [EPC]"], "product_ndc": "0404-9905", "generic_name": "Mannitol", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mannitol", "active_ingredients": [{"name": "MANNITOL", "strength": "12.5 g/50mL"}], "application_number": "NDA016269", "marketing_category": "NDA", "marketing_start_date": "20220112", "listing_expiration_date": "20261231"}