Home NDC 0264-7850 Sterile Water
Product NDC 0264-7850
11-digit product format 002647850
Labeler code 0264
Product ID 0264-7850_f7c681df-db56-42c6-846f-4e0672c4d553
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Water
Dosage form INJECTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application NDA019633
Marketing category NDA
Marketing start 1988-02-24
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 44 .
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 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID / N/A AP RLD, RS 1988-02-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019633-001 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 · 44 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 2026-10-15 13:18:30 2026-09 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019633-001 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100% LIQUID / N/A AP RLD, RS 1988-02-29 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 N019633-001 AP 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019633-001 AP 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019633-001 AP 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019633-001 AP 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0264-7850-00 Sterile Water 12 in 1 CASE INJECTION 12 15 0264-7850-00 Sterile Water 1000 mL in 1 CONTAINER INJECTION 1000 15 0264-7850-10 Sterile Water 24 in 1 CASE INJECTION 24 15 0264-7850-10 Sterile Water 500 mL in 1 CONTAINER INJECTION 500 15 0264-7850-20 Sterile Water 24 in 1 CASE INJECTION 24 15 0264-7850-20 Sterile Water 250 mL in 1 CONTAINER INJECTION 250 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-7850 STERILE WATER (WATER) INJECTION [B. BRAUN MEDICAL INC.] 15 Current NDC, Legacy NDC, 6 package rows 20240612_8fc8d87a-3951-4ac5-97df-c161ffc90475.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 Marketing end Sample Exclude flag Status 0264-7850-00 00264785000 12 CONTAINER in 1 CASE (0264-7850-00) / 1000 mL in 1 CONTAINER 12 container 1988-02-24 0000-00-00 No No Current 0264-7850-10 00264785010 24 CONTAINER in 1 CASE (0264-7850-10) / 500 mL in 1 CONTAINER 24 container 1988-02-24 0000-00-00 No No Current 0264-7850-20 00264785020 24 CONTAINER in 1 CASE (0264-7850-20) / 250 mL in 1 CONTAINER 24 container 1988-02-24 0000-00-00 No No Current