Sterile Water

Product NDC: 64253-020
Requested package NDC: 64253-020-52
11-digit product format: 642530020
Labeler code: 64253
Product ID: 64253-020_2b39b41d-419a-dab8-e063-6394a90a319a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sterile Water for Injection
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Medefil, Inc.
Application: ANDA211188
Marketing category: ANDA
Marketing start: 2020-01-27
Substance: WATER
Active strength: 100 mL/100mL
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211188-001	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02
A211188-002	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02
A211188-003	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02
A211188-004	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02
A211188-005	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211188-004	AP
A211188-005	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 5 · 190 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
2026-02-19 14:30 UTC	2026-02	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211188-001	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID / N/A			2019-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211188-002	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID / N/A		RS	2019-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211188-003	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID / N/A		RS	2019-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211188-004	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID / N/A	AP	RS	2019-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211188-005	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID / N/A	AP		2019-12-02	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 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	A211188-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211188-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211188-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211188-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211188-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211188-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211188-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211188-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211188-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211188-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211188-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211188-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211188-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211188-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211188-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211188-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211188-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211188-004	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211188-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211188-004	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211188-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211188-004	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211188-005	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211188-004	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211188-005	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211188-004	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211188-005	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211188-004	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211188-005	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211188-004	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211188-005	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211188-005	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211188-005	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211188-005	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211188-005	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211188-005	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211188-005	AP	1	`c0c555d07b60…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sterile Water
Listing expiration: 2026-12-31

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
99e99a50-82d5-aff6-e053-2a95a90a8c56	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64253-020-21	2022-02-04	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-23	2022-02-04	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-25	2022-02-04	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-30	2022-02-04	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-35	2022-02-04	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-52	2022-02-04	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-91	2022-02-04	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-21	2022-01-28	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-23	2022-01-28	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-25	2022-01-28	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-30	2022-01-28	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-35	2022-01-28	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-52	2022-01-28	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019
64253-020-91	2022-01-28	These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64253-020-21	Sterile Water	1 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	1	5
64253-020-21	Sterile Water	60 in 1 BOX	INJECTION, SOLUTION	60	5
64253-020-23	Sterile Water	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3	5
64253-020-23	Sterile Water	60 in 1 BOX	INJECTION, SOLUTION	60	5
64253-020-25	Sterile Water	5 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	5	5
64253-020-25	Sterile Water	60 in 1 BOX	INJECTION, SOLUTION	60	5
64253-020-30	Sterile Water	60 in 1 BOX	INJECTION, SOLUTION	60	5
64253-020-30	Sterile Water	10 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	10	5
64253-020-35	Sterile Water	60 in 1 BOX	INJECTION, SOLUTION	60	5
64253-020-35	Sterile Water	5 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	5	5
64253-020-52	Sterile Water	60 in 1 BOX	INJECTION, SOLUTION	60	5
64253-020-52	Sterile Water	2.5 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	2.5	5
64253-020-91	Sterile Water	10 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	10	5
64253-020-91	Sterile Water	10 in 1 BOX	INJECTION, SOLUTION	10	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64253-020-30	ML - Milliliter	64253-020	6269e8d5-444a-4269-84e8-1597dd7c6fb2	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64253-020	STERILE WATER (STERILE WATER FOR INJECTION) INJECTION, SOLUTION [MEDEFIL, INC.]	5	Current NDC, Legacy NDC, 14 package rows	20250110_99e99a50-82d5-aff6-e053-2a95a90a8c56.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	STERILE WATER FOR INJECTION	Medefil, Inc.	99e99a50-82d5-aff6-e053-2a95a90a8c56	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211188 application number: ANDA211188 ndc (package): 64253-020-52 ndc (product): 64253-020 ndc11 (package): 64253002052

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
64253-020-52	64253002052	60 SYRINGE, PLASTIC in 1 BOX (64253-020-52) / 2.5 mL in 1 SYRINGE, PLASTIC	2020-01-27	0000-00-00	No	No	Current