Application 018893

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM ACETATE	SODIUM ACETATE	INJECTABLE;INJECTION	2MEQ/ML	Yes	Yes
002	SODIUM ACETATE	SODIUM ACETATE	SOLUTION;INTRAVENOUS	100MEQ/50ML (2MEQ/ML)	Yes	Yes
003	SODIUM ACETATE	SODIUM ACETATE	SOLUTION;INTRAVENOUS	200MEQ/100ML (2MEQ/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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018893-001	SODIUM ACETATE	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04
N018893-002	SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02
N018893-003	SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N018893-001	AP
N018893-002	AP
N018893-003	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 · 71 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	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018893-002	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018893-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018893-001	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1983-05-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 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	N018893-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018893-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018893-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018893-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018893-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018893-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018893-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018893-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018893-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018893-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018893-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018893-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018893-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018893-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018893-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018893-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018893-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018893-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018893-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018893-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018893-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018893-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018893-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018893-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018893-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018893-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018893-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018893-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018893-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018893-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018893-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018893-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018893-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018893-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018893-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018893-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018893-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018893-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018893-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018893-001	AP	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Acetate	SODIUM ACETATE	Hospira, Inc.	ce9a7469-c4ba-4f60-8f7a-47ef0974316e	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018893 application number: NDA018893 ndc (product): 0409-7299
Sodium Acetate	SODIUM ACETATE	Hospira, Inc.	c91ede49-c7cc-47b7-0f93-e6841dd5916a	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018893 application number: NDA018893 ndc (product): 0409-7299
Sodium Acetate	SODIUM ACETATE	Hospira, Inc.	abc41ed1-9512-4bea-9295-1a9ca134b6c2	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018893 application number: NDA018893 ndc (product): 0409-3299
Sodium Acetate	SODIUM ACETATE	Hospira, Inc.	c3be2468-45e8-4ecc-a30b-e966743a563f	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018893 application number: NDA018893 ndc (product): 0409-3299

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-3299	Sodium Acetate	sodium acetate	Hospira, Inc.	NDA	Current
0409-3299	Sodium Acetate	sodium acetate	Hospira, Inc.	NDA	Current
0409-3299	Sodium Acetate	sodium acetate	Hospira, Inc.	NDA	Current
0409-3299	Sodium Acetate	sodium acetate	Hospira, Inc.	NDA	Current
0409-3299	Sodium Acetate	sodium acetate	Hospira, Inc.	NDA	Current
0409-3299	Sodium Acetate	sodium acetate	Hospira, Inc.	NDA	Current
0409-7299	Sodium Acetate	SODIUM ACETATE	Hospira, Inc.	NDA	Current
0409-7299	Sodium Acetate	SODIUM ACETATE	Hospira, Inc.	NDA	Current
0409-7299	Sodium Acetate	SODIUM ACETATE	Hospira, Inc.	NDA	Current
0409-7299	Sodium Acetate	SODIUM ACETATE	Hospira, Inc.	NDA	Current
0409-7299	Sodium Acetate	SODIUM ACETATE	Hospira, Inc.	NDA	Current
0409-7299	Sodium Acetate	SODIUM ACETATE	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33637	SUPPL	2014-09-03
1121	SUPPL	2003-03-10