Application 018802

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	LIQUID;N/A	100%	Yes	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…`

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 ndc (product): 0409-3977
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 ndc (product): 51662-1473
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 ndc (product): 71872-7129

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9970	Bacteriostatic Water	Water	Henry Schein, Inc.	NDA	Current
0404-9970	Bacteriostatic Water	Water	Henry Schein, Inc.	NDA	Current
0409-3977	Bacteriostatic Water	Bacteriostatic Water	Hospira, Inc.	NDA	Current
0409-3977	Bacteriostatic Water	Bacteriostatic Water	Hospira, Inc.	NDA	Current
0409-3977	Bacteriostatic Water	Bacteriostatic Water	Hospira, Inc.	NDA	Current
51662-1473	BACTERIOSTATIC WATER	BACTERIOSTATIC WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1473	BACTERIOSTATIC WATER	BACTERIOSTATIC WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-977	Bacteriostatic Water	Water	General Injectables & Vaccine, Inc	NDA	Current
52584-977	Bacteriostatic Water	Water	General Injectables & Vaccine, Inc	NDA	Current
52584-977	Bacteriostatic Water	Water	General Injectables & Vaccine, Inc	NDA	Current
52584-977	Bacteriostatic Water	Water	General Injectables & Vaccine, Inc	NDA	Current
52584-977	Bacteriostatic Water	Water	General Injectables & Vaccine, Inc	NDA	Current
61699-3977	Bacteriostatic Water	WATER	US MedSource, LLC	NDA	Current
70518-1236	Bacteriostatic Water	Bacteriostatic Water	REMEDYREPACK INC.	NDA	Current
70518-1236	Bacteriostatic Water	Bacteriostatic Water	REMEDYREPACK INC.	NDA	Current
71872-7129	Bacteriostatic Water	WATER	Medical Purchasing Solutions, LLC	NDA	Current
71872-7129	Bacteriostatic Water	WATER	Medical Purchasing Solutions, LLC	NDA	Current