Home NDC 65219-495 Sterile Water
Product NDC 65219-495
11-digit product format 652190495
Labeler code 65219
Product ID 65219-495_7cd9f528-a5da-4541-bb2a-28f3669a6b42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Water
Dosage form INJECTION
Route IRRIGATION
Labeler Fresenius Kabi USA, LLC
Application ANDA216123
Marketing category ANDA
Marketing start 2025-12-19
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216123-001 STERILE WATER FOR IRRIGATION STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216123-001 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216123-001 STERILE WATER FOR IRRIGATION 100% LIQUID / IRRIGATION AT 2024-08-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sterile Water
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WATER 1 mL/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 059QF0KO0R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 150985 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65219-495-01 Sterile Water 1000 mL in 1 BAG INJECTION 1000 4 65219-495-10 Sterile Water 6 in 1 CASE INJECTION 6 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-495 STERILE WATER (WATER) INJECTION [FRESENIUS KABI USA, LLC] 2 Current NDC, 2 package rows 20250402_fd823bef-c14c-4708-a18a-8aaa8470412f.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-495-01 65219049501 1000 mL in 1 BAG 1000 ml Historical 65219-495-10 65219049510 6 BAG in 1 CASE (65219-495-10) / 1000 mL in 1 BAG (65219-495-01) 6 bag 2025-12-19 No No Current