MedPath

Sterile Water

Sterile Water for Injection, USP

Approved
Approval ID

bc04a883-babc-87a6-e053-2995a90a3dfd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 4, 2021

Manufacturers
FDA

Nephron Pharmaceuticals Corporation

DUNS: 079160190

Products 1

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

Sterile Water

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0487-6105
Application NumberANDA211222
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sterile Water
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateJune 4, 2021
FDA Product Classification

INGREDIENTS (1)

WATERActive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Sterile Water - FDA Drug Approval Details