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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)
| 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 |
| Pricing Information | |
| 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 |
Standard Product Labeling (SPL)/Prescribing Information SPL 78b35864-4bbc-4759-a5c1-7e4f25e22932 Details
DESCRIPTION:
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
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 - 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
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. 5/18
INGREDIENTS AND APPEARANCE
| STERILE WATER
water injection, solution |
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| STERILE WATER
water injection, solution |
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| STERILE WATER
water injection, solution |
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| Labeler - American Regent, Inc. (002033710) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| American Regent, Inc. | 002033710 | analysis(0517-3005, 0517-3010, 0517-3020) , manufacture(0517-3005, 0517-3010, 0517-3020) | |