Sterile Water

Product NDC
17271-802
11-digit product format
172710802
Labeler code
17271
Product ID
17271-802_cab03cda-4660-4020-a3be-bf86242ff664
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Water
Dosage form
INJECTION
Route
IRRIGATION
Labeler
Becton Dickinson and Company
Application
ANDA216123
Marketing category
ANDA
Marketing start
2025-11-14
Substance
WATER
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216123-001STERILE WATER FOR IRRIGATIONSTERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A216123-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-12d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216123-001STERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONAT2024-08-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216123-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216123-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216123-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216123-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216123-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216123-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216123-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216123-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216123-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216123-001AT1d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216123-001AT1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Sterile Water
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
059QF0KO0RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
150985Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cab03cda-4660-4020-a3be-bf86242ff664Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17271-802-07Sterile Water1000 mL in 1 BAGINJECTION10001
17271-802-07Sterile Water6 in 1 CASEINJECTION61
17271-802-08Sterile Water2000 mL in 1 BAGINJECTION20001
17271-802-08Sterile Water5 in 1 CASEINJECTION51
17271-802-09Sterile Water3000 mL in 1 BAGINJECTION30001
17271-802-09Sterile Water4 in 1 CASEINJECTION41

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216123
application number: ANDA216123
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216123
application number: ANDA216123
ndc (product): 17271-802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
150985water 100 % Irrigation SolutionPSNcab03cda-4660-4020-a3be-bf86242ff6641
150985water 1000 MG/ML Irrigation SolutionSCDcab03cda-4660-4020-a3be-bf86242ff6641
150985water 100 % Irrigation SolutionSYcab03cda-4660-4020-a3be-bf86242ff6641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17271-802-07172710802076 BAG in 1 CASE (17271-802-07) / 1000 mL in 1 BAG6 bag2026-01-02NoNoCurrent
17271-802-08172710802085 BAG in 1 CASE (17271-802-08) / 2000 mL in 1 BAG5 bag2026-01-02NoNoCurrent
17271-802-09172710802094 BAG in 1 CASE (17271-802-09) / 3000 mL in 1 BAG4 bag2025-11-14NoNoCurrent