mannitol

Generic: mannitol

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mannitol
Generic Name mannitol
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

mannitol 12.5 g/50mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1468
Product ID 51662-1468_0ffaf004-4d61-3fd4-e063-6294a90a1a63
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016269
Listing Expiration 2026-12-31
Marketing Start 2019-12-13

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 516621468
Hyphenated Format 51662-1468

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
  • 50 mL in 1 VIAL, SINGLE-DOSE (51662-1468-1)
  • 25 POUCH in 1 CASE (51662-1468-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1468-2) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

51662-1468-1 50 mL in 1 VIAL, SINGLE-DOSE (51662-1468-1) 51662-1468-3 25 POUCH in 1 CASE (51662-1468-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1468-2) / 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": "0ffaf004-4d61-3fd4-e063-6294a90a1a63", "openfda": {"nui": ["N0000175359", "N0000010288", "N0000175810"], "unii": ["3OWL53L36A"], "rxcui": ["311450"], "spl_set_id": ["999ce711-2d5b-0d7d-e053-2995a90a2689"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Osmotic Diuretic [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 VIAL, SINGLE-DOSE (51662-1468-1)", "package_ndc": "51662-1468-1", "marketing_start_date": "20191213"}, {"sample": false, "description": "25 POUCH in 1 CASE (51662-1468-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1468-2)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1468-3", "marketing_start_date": "20221211"}], "brand_name": "MANNITOL", "product_id": "51662-1468_0ffaf004-4d61-3fd4-e063-6294a90a1a63", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Increased Diuresis [PE]", "Osmotic Activity [MoA]", "Osmotic Diuretic [EPC]"], "product_ndc": "51662-1468", "generic_name": "MANNITOL", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "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": "20191213", "listing_expiration_date": "20261231"}