Home NDC 55154-9588 Sterile Water
Product NDC 55154-9588
11-digit product format 551549588
Labeler code 55154
Product ID 55154-9588_5ce57948-f7bb-4676-8874-824e5f511e8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name WATER
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Cardinal Health 107, LLC
Application ANDA088400
Marketing category ANDA
Marketing start 2024-10-31
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 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 1984-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088400-001 AP
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.
Product history page 1 of 2 · 42 observed 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 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088400-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP 1984-01-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 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 55154-9588-5 Sterile Water 5 in 1 BAG INJECTION 5 2 55154-9588-5 Sterile Water 10 mL in 1 VIAL INJECTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-9588 STERILE WATER (WATER) INJECTION [CARDINAL HEALTH 107, LLC] 1 Current NDC, 2 package rows 20241103_48d75a7c-8329-48a8-bea0-a8c144ddf637.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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55154-9588-5 55154958805 5 VIAL in 1 BAG (55154-9588-5) / 10 mL in 1 VIAL 5 vial 2024-10-31 No No Current