Search by Drug Name or NDC

NDC 00517-3020-25 Sterile Water 1 mL/mL Details

Sterile Water 1 mL/mL

Sterile Water is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by American Regent, Inc.. The primary component is WATER.

Product Information

NDC	00517-3020
Product ID	0517-3020_b885fb92-786e-49bf-aed2-17b430e4743e
Associated GPIs	98401010002000
GCN Sequence Number	001167
GCN Sequence Number Description	water for injection,sterile VIAL INJECTION
HIC3	C0B
HIC3 Description	WATER
GCN	02709
HICL Sequence Number	000517
HICL Sequence Number Description	WATER FOR INJECTION,STERILE
Brand/Generic	Generic
Proprietary Name	Sterile Water
Proprietary Name Suffix	n/a
Non-Proprietary Name	Water
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	INJECTION, SOLUTION
Route	INTRAVENOUS
Active Ingredient Strength	1
Active Ingredient Units	mL/mL
Substance Name	WATER
Labeler Name	American Regent, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00517-3020-25 (00517302025)

Pricing Information
NDC Package Code	0517-3020-25
Billing NDC	00517302025
Package	25 VIAL, SINGLE-DOSE in 1 TRAY (0517-3020-25) / 20 mL in 1 VIAL, SINGLE-DOSE (0517-3020-01)
Marketing Start Date	2022-04-22
NDC Exclude Flag	N
Price Per Unit	0.06107
Pricing Unit	ML
Effective Date	2023-10-18
NDC Description	WATER FOR INJECTION VIAL
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 78b35864-4bbc-4759-a5c1-7e4f25e22932 Details

SPL UNCLASSIFIED SECTION

Rx Only

WARNING

NOT FOR DIRECT INJECTION

DESCRIPTION:

Sterile Water for Injection, USP is water for injection sterilized and packaged in single dose vials. It contains no antimicrobial agents or other preservatives. It is used as a diluent. Non-pyrogenic.

PRECAUTIONS:

Unused amount should be discarded immediately following withdrawal of any portion of vial contents. Sterile Water for Injection is not isotonic and should not be injected directly into the body.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

HOW SUPPLIED:

Sterile Water for Injection, USP

NDC 0517-3005-25	5 mL Single Dose Vial	Packaged in 25
NDC 0517-3010-25	10 mL Single Dose Vial	Packaged in 25
NDC 0517-3020-25	20 mL Single Dose Vial	Packaged in 25
NDC 0517-3050-25	50 mL Single Dose Vial	Packaged in 25

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

IN3005

Rev. 1/09

PRINCIPAL DISPLAY PANEL - 5 mL

Contain

NDC 0517-3005-01

STERILE WATER

FOR INJECTION, USP

5 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Carton

STERILE WATER

FOR INJECTION, USP

NDC 0517-3005-25

25 x 5 mL

SINGLE DOSE VIALS

FOR DRUG DILUENT USE

Rx Only

No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

PRINCIPAL DISPLAY PANEL - 10 mL

Container

NDC 0517-3010-01

STERILE WATER

FOR INJECTION, USP

10 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Carton

STERILE WATER

FOR INJECTION, USP

NDC 0517-3010-25

25 x 10 mL

SINGLE DOSE VIALS

FOR DRUG DILUENT USE

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

PRINCIPAL DISPLAY PANEL - 20 mL

Container

NDC 0517-3020-01

STERILE WATER

FOR INJECTION, USP

20 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Carton

STERILE WATER

FOR INJECTION, USP

NDC 0517-3020-25

25 x 20 mL

SINGLE DOSE VIALS

FOR DRUG DILUENT USE

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Rev. 5/18

Serialization Label - 5 mL

Serialization Label - 10 mL

Serialization Label - 20 mL

INGREDIENTS AND APPEARANCE

STERILE WATER

water injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0517-3005
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1 mL in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0517-3005-25	25 in 1 TRAY	09/30/1990	09/30/2021
1	NDC:0517-3005-01	5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/30/1990	09/30/2021

STERILE WATER

water injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0517-3010
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1 mL in 1 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0517-3010-25	25 in 1 TRAY	04/22/2022
1	NDC:0517-3010-01	10 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/22/2022

STERILE WATER

water injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0517-3020
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1 mL in 1 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0517-3020-25	25 in 1 TRAY	04/22/2022
1	NDC:0517-3020-01	20 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/22/2022

Labeler - American Regent, Inc. (002033710)

Name	Address	ID/FEI	Business Operations
Establishment
American Regent, Inc.		002033710	analysis(0517-3005, 0517-3010, 0517-3020) , manufacture(0517-3005, 0517-3010, 0517-3020)

Revised: 1/2022

Document Id: b885fb92-786e-49bf-aed2-17b430e4743e

Set id: 78b35864-4bbc-4759-a5c1-7e4f25e22932

Version: 8

Effective Time: 20220131

Search by Drug Name or NDC

NDC 00517-3020-25 Sterile Water 1 mL/mL Details

Sterile Water 1 mL/mL

Product Information

Package

Package Images

NDC 00517-3020-25 (00517302025)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 78b35864-4bbc-4759-a5c1-7e4f25e22932 Details

SPL UNCLASSIFIED SECTION

WARNING

DESCRIPTION:

PRECAUTIONS:

HOW SUPPLIED:

PRINCIPAL DISPLAY PANEL - 5 mL

PRINCIPAL DISPLAY PANEL - 10 mL

PRINCIPAL DISPLAY PANEL - 20 mL

Serialization Label - 5 mL

Serialization Label - 10 mL

Serialization Label - 20 mL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?