Sterile Water

Product NDC: 0641-6147
11-digit product format: 006416147
Labeler code: 0641
Product ID: 0641-6147_081540ac-58cf-437f-ba1b-86d5264ec3dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: WATER
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA206369
Marketing category: ANDA
Marketing start: 2015-09-03
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 1.

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 2 · 79 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	A206369-002	STERILE WATER FOR INJECTION	100% (20ML)	LIQUID / N/A		2015-09-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206369-001	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP	2015-09-02	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206369-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206369-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206369-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206369-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206369-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206369-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206369-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206369-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206369-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206369-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206369-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206369-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206369-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206369-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206369-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206369-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206369-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206369-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206369-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206369-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206369-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206369-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206369-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206369-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206369-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206369-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206369-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206369-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206369-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206369-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206369-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206369-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206369-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206369-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206369-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206369-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206369-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206369-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206369-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206369-001	AP	1	`cb3db0bc1861…`

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
78ef7ad3-451d-43d0-a9b6-5cf0aadca003	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0641-6147-01	Sterile Water	10 mL in 1 VIAL	INJECTION, SOLUTION	10	12
0641-6147-10	Sterile Water	10 in 1 CARTON	INJECTION, SOLUTION	10	12
0641-6147-25	Sterile Water	25 in 1 CARTON	INJECTION, SOLUTION	25	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6147-01	ML - Milliliter	0641-6147	64ef0224-9469-4b15-98fa-4ae09f98ac0e	1	2018-08-13
0641-6147-10	ML - Milliliter	0641-6147	0495bb78-5321-4be7-b963-f68ffc4bb2b4	1	2019-11-12
0641-6147-25	ML - Milliliter	0641-6147	3a15b7df-eeee-445c-b2c2-bf211870cd79	1	2018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
WATER	ACTIVE INGREDIENT	059QF0KO0R	STERILE WATER (WATER) INJECTION, SOLUTION [WEST-WARD PHARMACEUTICALS CORP.]	6
WATER	ACTIVE MOIETY	059QF0KO0R	STERILE WATER (WATER) INJECTION, SOLUTION [WEST-WARD PHARMACEUTICALS CORP.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6147	STERILE WATER (WATER) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	12	Current NDC, Legacy NDC, 3 package rows	20240412_78ef7ad3-451d-43d0-a9b6-5cf0aadca003.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 INJECTION	Henry Schein, Inc.	3501952b-b556-4d5e-b81b-5c35ff87b475	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206369 application number: ANDA206369
Sterile Water	WATER	Hikma Pharmaceuticals USA Inc.	78ef7ad3-451d-43d0-a9b6-5cf0aadca003	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206369 application number: ANDA206369 ndc (product): 0641-6147
Sterile Water	WATER	Civica, Inc.	3f49eedf-5bf5-4a95-b704-c956d860ca04	2023-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206369 application number: ANDA206369

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
0641-6147-01	00641614701	10 mL in 1 VIAL	10 ml					Historical
0641-6147-10	00641614710	10 VIAL in 1 CARTON (0641-6147-10) / 10 mL in 1 VIAL (0641-6147-01)	10 vial	2015-09-03	0000-00-00	No	No	Current
0641-6147-25	00641614725	25 VIAL in 1 CARTON (0641-6147-25) / 10 mL in 1 VIAL (0641-6147-01)	25 vial	2015-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sterile Water for Injection USP	Henry Schein, Inc.	2025-08-28	HUMAN PRESCRIPTION DRUG LABEL	1
Sterile Water for Injection, USP	Hikma Pharmaceuticals USA Inc.	2024-04-10	HUMAN PRESCRIPTION DRUG LABEL	12
Sterile Water	General Injectables and Vaccines, Inc.	2019-06-19	HUMAN PRESCRIPTION DRUG LABEL	1