Application 018892

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INJECTABLE;INJECTION	142MG/ML;276MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018892-001	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 · 41 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	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION		RLD, RS	1983-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018892-001	SODIUM PHOSPHATES IN PLASTIC CONTAINER	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-05-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018892-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018892-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018892-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018892-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018892-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018892-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018892-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018892-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018892-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018892-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018892-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018892-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018892-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018892-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018892-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018892-001	AP	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018892-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018892-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018892-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018892-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018892-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018892-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018892-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018892-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018892-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018892-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018892-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018892-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018892-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018892-001	AP	1	`a50c72e98297…`

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
Sodium Phosphates	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	Hospira, Inc.	6f044d16-295e-43ff-72a3-b045c387bc5c	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018892 application number: NDA018892 ndc (product): 0409-7391

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7391	Sodium Phosphates	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE and SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	Hospira, Inc.	NDA	Current
0409-7391	Sodium Phosphates	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE and SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	Hospira, Inc.	NDA	Current
0409-7391	Sodium Phosphates	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE and SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77290	SUPPL	2024-01-24
77289	SUPPL	2024-01-24
1120	SUPPL	2002-03-14