Home NDC 0404-9781 Sterile Water
Product NDC 0404-9781
11-digit product format 004049781
Labeler code 0404
Product ID 0404-9781_d2b21939-b988-410f-830c-e36a4b7f447f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name water injection
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Henry Schein, Inc.
Application ANDA206369
Marketing category ANDA
Marketing start 2025-08-28
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206369-001 STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 A206369-002 STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206369-001 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 3 · 81 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 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206369-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2015-09-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206369-002 STERILE WATER FOR INJECTION 100% (20ML) LIQUID / N/A 2015-09-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206369-001 STERILE WATER FOR INJECTION 100% (10ML) LIQUID / N/A AP 2015-09-02 782e0a99824c…
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 0404-9781-10 Sterile Water 10 mL in 1 VIAL INJECTION, SOLUTION 10 1 0404-9781-10 Sterile Water 1 in 1 BAG INJECTION, SOLUTION 1 1
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 0404-9781-10 00404978110 1 VIAL in 1 BAG (0404-9781-10) / 10 mL in 1 VIAL 1 vial 2025-08-28 No No Current