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Nacellate Solution 0.9% - 500mL

Nacellate Solution 0.9% - 500mL

Approved
Approval ID

f648434a-c642-4677-9a54-eb49058f8362

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 23, 2022

Manufacturers
FDA

IT3 Medical LLC

DUNS: 079971231

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70529-023
Application NumberNDA016677
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2018
FDA Product Classification

INGREDIENTS (2)

SODIUM CHLORIDEActive
Quantity: 9 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Nacellate Solution 0.9% - 500mL - FDA Drug Approval Details