Sterile Water

Product NDC: 0338-0013
11-digit product format: 003380013
Labeler code: 0338
Product ID: 0338-0013_0d547c0b-bb85-4caa-a4e4-a11a617d2d15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Water
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Company
Application: NDA018632
Marketing category: NDA
Marketing start: 1982-06-30
Substance: WATER
Active strength: 100 mL/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30
N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N018632-001	AP
N018632-002	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 · 86 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
2026-09-14 22:38:34	2026-08	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018632-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018632-002	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1988-04-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N018632-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018632-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018632-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018632-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018632-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018632-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018632-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018632-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018632-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018632-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018632-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018632-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018632-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018632-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018632-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018632-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018632-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018632-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018632-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018632-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018632-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018632-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018632-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018632-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018632-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018632-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018632-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018632-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018632-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018632-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018632-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018632-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018632-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018632-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018632-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018632-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018632-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018632-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018632-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018632-002	AP	1	`74a2ff9319b5…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sterile Water
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WATER	100 mL/100mL

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
8bcf5572-49e1-4302-9522-56f57904cb4a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0338-0013-06	Sterile Water	2000 mL in 1 BAG	INJECTION, SOLUTION	2000	13
0338-0013-08	Sterile Water	3000 mL in 1 BAG	INJECTION, SOLUTION	3000	13
0338-0013-29	Sterile Water	5000 mL in 1 BAG	INJECTION, SOLUTION	5000	13
0338-0013-04	Sterile Water	1000 mL in 1 BAG	INJECTION, SOLUTION	1000	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0013-04	ML - Milliliter	0338-0013	d3498280-634e-48ac-83b7-2b720b064621	1	2012-07-24
0338-0013-06	ML - Milliliter	0338-0013	3ca8dace-1947-4c4d-9d6f-468ae9457d49	1	2012-07-24
0338-0013-08	ML - Milliliter	0338-0013	e1df3eb0-9545-4d31-aa4c-f2d5e3c9d324	1	2012-07-24
0338-0013-29	ML - Milliliter	0338-0013	4b54c7da-e882-49c8-85ff-2fecbc6591e7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WATER	ACTIVE INGREDIENT	059QF0KO0R	STERILE WATER (WATER) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]	5
WATER	ACTIVE MOIETY	059QF0KO0R	STERILE WATER (WATER) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]	5
WATER	ACTIVE INGREDIENT	059QF0KO0R	STERILE WATER (WATER) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]	4
WATER	ACTIVE MOIETY	059QF0KO0R	STERILE WATER (WATER) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0013	STERILE WATER (WATER) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]	11	Current NDC, Legacy NDC, 1 package rows	20250529_8bcf5572-49e1-4302-9522-56f57904cb4a.zip
0338-0013	STERILE WATER (WATER) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]	11	Current NDC, Legacy NDC, 3 package rows	20240907_210dc9ab-d6ca-4552-ac19-1be17792d290.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018632 application number: NDA018632 ndc (product): 0338-0013
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018632 application number: NDA018632 ndc (product): 0338-0013

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
0338-0013-04	00338001304	1000 mL in 1 BAG (0338-0013-04)	1000 ml	1982-06-30	0000-00-00	No	No	Current
0338-0013-06	00338001306	2000 mL in 1 BAG (0338-0013-06)	2000 ml	1982-06-30	0000-00-00	No	No	Current
0338-0013-08	00338001308	3000 mL in 1 BAG (0338-0013-08)	3000 ml	1982-06-30	0000-00-00	No	No	Current
0338-0013-29	00338001329	5000 mL in 1 BAG (0338-0013-29)	5000 ml	1982-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sterile Water for Injection, USP in VIAFLEX Plastic Container For Drug Diluent Use Only	Baxter Healthcare Company \| Baxter Healthcare Corporation	2019-12-29	HUMAN PRESCRIPTION DRUG LABEL	12
Sterile Water	Baxter Healthcare Company \| Baxter Healthcare Corporation	2016-05-31	HUMAN PRESCRIPTION DRUG LABEL	13