Sterile Water

Product NDC: 0264-7385
11-digit product format: 002647385
Labeler code: 0264
Product ID: 0264-7385_ed933e44-2560-495b-879c-99c6a0bf8ba0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Water
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: B. Braun Medical Inc.
Application: NDA019633
Marketing category: NDA
Marketing start: 2014-09-04
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
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 · 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	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…`
2022-10-28 04:53 UTC	2022-10	N019633-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-02-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019633-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-02-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019633-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019633-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019633-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019633-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019633-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019633-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019633-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019633-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019633-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019633-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019633-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019633-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019633-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019633-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019633-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019633-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019633-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019633-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019633-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019633-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019633-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019633-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019633-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019633-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019633-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019633-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019633-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019633-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019633-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019633-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019633-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019633-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019633-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019633-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019633-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019633-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019633-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019633-001	AP	1	`3a93d1ddd44b…`
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…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8924e52e-8622-4ed6-a061-1908183e0a18	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0264-7385-50	Sterile Water	2000 mL in 1 CONTAINER	INJECTION	2000	6
0264-7385-50	Sterile Water	4 in 1 CASE	INJECTION	4	6
0264-7385-60	Sterile Water	3000 mL in 1 CONTAINER	INJECTION	3000	6
0264-7385-60	Sterile Water	4 in 1 CASE	INJECTION	4	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0264-7385-50	ML - Milliliter	0264-7385	a27107d4-7eb2-406e-9bc2-a2577bcfbaaf	1	2015-05-05
0264-7385-60	ML - Milliliter	0264-7385	8f4e41b3-7c21-4c34-a263-b364cd18af75	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
WATER	ACTIVE INGREDIENT	059QF0KO0R	STERILE WATER (WATER) INJECTION [B. BRAUN MEDICAL INC.]	2
WATER	ACTIVE MOIETY	059QF0KO0R	STERILE WATER (WATER) INJECTION [B. BRAUN MEDICAL INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0264-7385	STERILE WATER (WATER) INJECTION [B. BRAUN MEDICAL INC.]	6	Current NDC, Legacy NDC, 4 package rows	20210814_8924e52e-8622-4ed6-a061-1908183e0a18.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	ProPharma Distribution	3f2ae880-852f-b45d-e063-6394a90aa1cc	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019633 application number: NDA019633
Sterile Water	WATER	B. Braun Medical Inc.	8fc8d87a-3951-4ac5-97df-c161ffc90475	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019633 application number: NDA019633
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019633 application number: NDA019633 ndc (product): 0264-7385

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
059QF0KO0R	WATER	7732-18-5	WATER

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0264-7385-50	00264738550	4 CONTAINER in 1 CASE (0264-7385-50) / 2000 mL in 1 CONTAINER	4 container	2014-09-04	0000-00-00	No	No	Current
0264-7385-60	00264738560	4 CONTAINER in 1 CASE (0264-7385-60) / 3000 mL in 1 CONTAINER	4 container	2014-09-04	0000-00-00	No	No	Current