Bacteriostatic Water

Product NDC: 0404-9970
11-digit product format: 004049970
Labeler code: 0404
Product ID: 0404-9970_020852cf-7148-4456-a0ce-d9845d7c3fe3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Water
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Henry Schein, Inc.
Application: NDA018802
Marketing category: NDA
Marketing start: 2022-01-17
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
N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018802-001	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	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018802-001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	RLD, RS	1982-10-27	`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	N018802-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018802-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018802-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018802-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018802-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018802-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018802-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018802-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018802-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018802-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018802-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018802-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018802-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018802-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018802-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018802-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018802-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018802-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018802-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018802-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018802-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018802-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018802-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018802-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018802-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018802-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018802-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018802-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018802-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018802-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018802-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018802-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018802-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018802-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018802-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018802-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018802-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018802-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018802-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018802-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bacteriostatic 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
a833502e-a622-4e81-8c58-cef6ccb6c4c9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9970-30	Bacteriostatic Water	1 in 1 BAG	INJECTION, SOLUTION	1		6
0404-9970-30	Bacteriostatic Water	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9970	BACTERIOSTATIC WATER (WATER) INJECTION, SOLUTION [HENRY SCHEIN, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240529_a833502e-a622-4e81-8c58-cef6ccb6c4c9.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bacteriostatic Water	BACTERIOSTATIC WATER	Hospira, Inc.	87d6e9dc-fe3b-4593-ac9a-d7493d1959c7	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018802 application number: NDA018802
Bacteriostatic Water	BACTERIOSTATIC WATER	ProPharma Distribution	42c6938e-f747-ae13-e063-6294a90a59a3	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018802 application number: NDA018802
Bacteriostatic Water	WATER	Henry Schein, Inc.	a833502e-a622-4e81-8c58-cef6ccb6c4c9	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018802 application number: NDA018802 ndc (product): 0404-9970
BACTERIOSTATIC WATER	BACTERIOSTATIC WATER	HF Acquisition Co LLC, DBA HealthFirst	99b0ef9b-600a-40dc-e053-2a95a90aa07e	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018802 application number: NDA018802
Bacteriostatic Water	WATER	Medical Purchasing Solutions, LLC	69485218-9343-952d-e053-2a91aa0ad4e8	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018802 application number: NDA018802

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9970-30	00404997030	1 VIAL, MULTI-DOSE in 1 BAG (0404-9970-30) / 30 mL in 1 VIAL, MULTI-DOSE	2022-01-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bacteriostatic Water Injection, USP 30 mL Multi Dose Vial	Henry Schein, Inc.	2025-10-27	HUMAN PRESCRIPTION DRUG LABEL	6