Medicine
Water 1 mL/mL injection
Water 1 mL/mL injection is a generic prescription medicine for irrigation use, made by 2 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F)., however, brief exposure up to 40°C…
Key facts
- Active ingredient (INN)
- Water
- Brand
- Sold under the generic name
- Strength
- 1 mL/mL
- Dosage form
- Injection
- Route
- Irrigation
- Packs
- 6 bags, 5 bags, 4 bags and 3 more
- Manufacturers
- Becton DickinsonFresenius Kabi
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F)., however, brief exposure up to 40°C (104°F) does not adversely affect the product.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 March 2025
- Identifiers
- RxCUI 150985DailyMed set ID fd823bef-c14c-4708-a18a-8aaa8470412f, cab03cda-4660-4020-a3be-bf86242ff664NDC 65219-497, 65219-495, 17271-802 +1Application ANDA216123
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 6 bag in 1 case / 1000 mL in 1 bag | 65219-495-10 | Fresenius Kabi | 19 December 2025 |
| 5 bag in 1 case / 2000 mL in 1 bag | 65219-497-20 | Fresenius Kabi | 19 December 2025 |
| 4 bag in 1 case / 3000 mL in 1 bag | 65219-499-30 | Fresenius Kabi | 3 March 2025 |
| 6 bag in 1 case / 1000 mL in 1 bag | 17271-802-07 | Becton Dickinson | 2 January 2026 |
| 5 bag in 1 case / 2000 mL in 1 bag | 17271-802-08 | Becton Dickinson | 2 January 2026 |
| 4 bag in 1 case / 3000 mL in 1 bag | 17271-802-09 | Becton Dickinson | 14 November 2025 |
| 4 container in 1 case / 2000 mL in 1 container | 0264-7385-50 | — | 4 September 2014 |
| 4 container in 1 case / 3000 mL in 1 container | 0264-7385-60 | — | 4 September 2014 |
| 12 container in 1 case / 1000 mL in 1 container | 0264-7850-00 | — | 24 February 1988 |
| 24 container in 1 case / 500 mL in 1 container | 0264-7850-10 | — | 24 February 1988 |
| 24 container in 1 case / 250 mL in 1 container | 0264-7850-20 | — | 24 February 1988 |
| 1000 mL in 1 bag | 0338-0013-04 | — | 30 June 1982 |
| 2000 mL in 1 bag | 0338-0013-06 | — | 30 June 1982 |
| 3000 mL in 1 bag | 0338-0013-08 | — | 30 June 1982 |
| 5000 mL in 1 bag | 0338-0013-29 | — | 30 June 1982 |
| 6 bag in 1 case / 2000 mL in 1 bag | 0990-7118-07 | — | 1 June 2019 |
| 12 pouch in 1 case / 1 bag in 1 pouch / 1000 mL in 1 bag | 0990-7990-09 | — | 1 October 2019 |
| 10 bag in 1 case / 1000 mL in 1 bag | 17271-750-07 | — | 28 February 2020 |
| 10 bag in 1 case / 1000 mL in 1 bag | 63323-178-76 | — | 24 November 2017 |
| 12 bag in 1 case / 1000 mL in 1 bag | 0143-9339-12 | — | 5 May 2023 |
| 500 mL in 1 container | 84549-850-10 | — | 18 September 2025 |
| 25 vial, single-dose in 1 tray / 10 mL in 1 vial, single-dose | 0409-0024-10 | — | 31 March 2025 |
| 25 vial, multi-dose in 1 tray / 30 mL in 1 vial, multi-dose | 0409-3977-03 | — | 30 April 2005 |
| 25 vial, plastic in 1 tray / 10 mL in 1 vial, plastic | 0409-4887-10 | — | 1 August 2005 |
| 25 vial, plastic in 1 tray / 20 mL in 1 vial, plastic | 0409-4887-20 | — | 16 June 2005 |
| 30 vial, plastic in 1 tray / 10 mL in 1 vial, plastic | 0409-4887-34 | — | 30 July 2015 |
| 25 vial, plastic in 1 tray / 50 mL in 1 vial, plastic | 0409-4887-50 | — | 4 August 2005 |
| 25 vial, glass in 1 case / 100 mL in 1 vial, glass | 0409-4887-99 | — | 3 August 2005 |
| 25 vial, single-dose in 1 tray / 5 mL in 1 vial, single-dose | 63323-185-05 | — | 30 April 2022 |
| 25 vial in 1 tray / 10 mL in 1 vial | 63323-185-10 | — | 5 September 2000 |
| 25 vial in 1 tray / 20 mL in 1 vial | 63323-185-20 | — | 5 September 2000 |
| 25 vial in 1 tray / 50 mL in 1 vial | 63323-185-50 | — | 5 September 2000 |
| 25 vial, single-dose in 1 tray / 100 mL in 1 vial, single-dose | 65219-187-10 | — | 29 April 2022 |
| 30 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 62135-833-84 | — | 25 January 2024 |
| 10 vial in 1 carton / 10 mL in 1 vial | 0641-6147-10 | — | 3 September 2015 |
| 25 vial in 1 carton / 10 mL in 1 vial | 0641-6147-25 | — | 3 September 2015 |
| 60 syringe, plastic in 1 box / 1 mL in 1 syringe, plastic | 64253-020-21 | — | 27 January 2020 |
| 60 syringe, plastic in 1 box / 3 mL in 1 syringe, plastic | 64253-020-23 | — | 27 January 2020 |
| 60 syringe, plastic in 1 box / 5 mL in 1 syringe, plastic | 64253-020-25 | — | 21 September 2020 |
| 60 syringe, plastic in 1 box / 10 mL in 1 syringe, plastic | 64253-020-30 | — | 27 January 2020 |
| 60 syringe, plastic in 1 box / 5 mL in 1 syringe, plastic | 64253-020-35 | — | 27 January 2020 |
| 60 syringe, plastic in 1 box / 2.5 mL in 1 syringe, plastic | 64253-020-52 | — | 27 January 2020 |
| 10 syringe, plastic in 1 box / 10 mL in 1 syringe, plastic | 64253-020-91 | — | 21 September 2020 |
| 30 vial, plastic in 1 carton / 5 mL in 1 vial, plastic | 0487-6105-01 | — | 16 June 2021 |
| 50 mL in 1 vial, plastic | 51662-1265-1 | — | 17 September 2018 |
| 100 mL in 1 vial, glass | 51662-1266-1 | — | 2 September 2018 |
| 10 mL in 1 vial, plastic | 51662-1329-1 | — | 8 October 2018 |
| 30 mL in 1 vial, multi-dose | 51662-1473-1 | — | 14 December 2019 |
| 20 mL in 1 vial, plastic | 51662-1474-1 | — | 14 December 2019 |
| 1 vial in 1 bag / 10 mL in 1 vial | 0404-9781-10 | — | 28 August 2025 |
| 1 vial, single-dose in 1 bag / 10 mL in 1 vial, single-dose | 0404-9959-10 | — | 12 January 2022 |
| 1 vial, single-dose in 1 bag / 20 mL in 1 vial, single-dose | 0404-9959-20 | — | 12 January 2022 |
| 1 vial, single-dose in 1 bag / 50 mL in 1 vial, single-dose | 0404-9959-50 | — | 12 January 2022 |
| 1 vial, glass in 1 bag / 100 mL in 1 vial, glass | 0404-9971-00 | — | 10 January 2022 |
| 5 vial, plastic in 1 bag / 10 mL in 1 vial, plastic | 55154-0127-5 | — | 15 September 2011 |
| 5 vial in 1 bag / 10 mL in 1 vial | 55154-9588-5 | — | 31 October 2024 |
| 50 mL in 1 vial, plastic | 84549-887-50 | — | 27 August 2025 |
| 30 mL in 1 vial, multi-dose | 84549-977-03 | — | 10 October 2025 |
| 25 vial, plastic in 1 tray / 10 mL in 1 vial, plastic | 50090-2874-1 | — | 17 February 2017 |
| 10 mL in 1 vial, plastic | 76420-082-10 | — | 9 April 2020 |
| 10 vial in 1 carton / 10 mL in 1 vial | 72572-747-10 | — | 23 February 2022 |
| 1 vial in 1 carton / 10 mL in 1 vial | 0002-0800-01 | — | 10 July 1987 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Water 1 mL/mL injection.
- Water 1 mL/mL injectionAvailable on request—US FDA40 packs
- Water 1 mL/mL injectionAvailable on request—US FDA15 packs
- Bacteriostatic Water 1 mL/mL injectionAvailable on requestHenry ScheinUS FDA2 packs
- Diluent 1 mL/mL injectionAvailable on requestSandozUS FDA1 pack
- INSULIN DILUTING MEDIUM FOR Kirsty 1 mL/mL injectionAvailable on requestBiocon BiologicsIndiaUS FDA1 pack Cold chain
- Insulin Diluting Medium for Garzulys 1 mL/mL injectionAvailable on requestMeitheal PharmaceuticalsUS FDA1 pack Cold chain
Other strengths and forms of Water
Clinical summary
Water is a prescription medicine indicated as an irrigating fluid or pharmaceutic aid. It is available as injection and irrigation solution for intravenous, subcutaneous and intramuscular use. MedsAcross supplies Water for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about WaterFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sterile Water prescribing information (B. Braun Medical) · U.S. National Library of Medicine, DailyMed
Need Water 1 mL/mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.