SODIUM ACETATE

Product NDC: 69784-231
Requested package NDC: 69784-231-20
11-digit product format: 697840231
Labeler code: 69784
Product ID: 69784-231_ef736af9-9b51-44da-e053-2995a90af28d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM ACETATE
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Woodward Pharma Services LLC
Application: ANDA214805
Marketing category: ANDA
Marketing start: 2021-06-01
Marketing end: 0000-00-00
Substance: SODIUM ACETATE
Active strength: 164 mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69784-231	69784-231-20	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214805-001	SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04
A214805-002	SODIUM ACETATE	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25
A214805-003	SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04
A214805-004	SODIUM ACETATE	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214805-001	AP
A214805-002	AP
A214805-003	AP
A214805-004	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 3 · 83 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	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214805-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-002	SODIUM ACETATE	400MEQ/100ML (4MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2023-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-003	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2021-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-004	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2024-01-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 83 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	A214805-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214805-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214805-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214805-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214805-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214805-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214805-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214805-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214805-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214805-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214805-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214805-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214805-004	AP	1	`d06236e962d9…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214805-001	CGT	2022-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214805-001	CGT	2022-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214805-001	CGT	2022-01-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214805-001	CGT	2022-01-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214805-001	CGT	2022-01-03	`782e0a99824c…`
2023-01-26 05:58 UTC	2023-01	A214805-001	CGT	2022-01-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214805-001	CGT	2022-01-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214805-001	CGT	2022-01-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214805-001	CGT	2022-01-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214805-001	CGT	2022-01-03	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69784-231-10	2025-09-18	SODIUM ACETATE Injection, USP
69784-231-20	2025-09-18	SODIUM ACETATE Injection, USP
69784-231-10	2025-01-30	SODIUM ACETATE Injection, USP
69784-231-20	2025-01-30	SODIUM ACETATE Injection, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69784-231-10	ML - Milliliter	69784-231	3e3959f0-d6bc-401d-aed2-ba726c8937e7	1	2023-10-16
69784-231-20	ML - Milliliter	69784-231	54144e19-0644-4308-9f5d-77ca26faaf69	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69784-231	SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [WOODWARD PHARMA SERVICES LLC]	6	Legacy NDC	20231104_dfa26fd6-53dd-499c-8c40-fd0623d2c8f1.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Acetate	SODIUM ACETATE	MILLA PHARMACEUTICALS INC.	1ea1466d-a492-4056-e063-6394a90a80bf	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214805 application number: ANDA214805
Sodium Acetate	SODIUM ACETATE	MILLA PHARMACEUTICALS INC.	1ea04916-78e5-4651-e063-6394a90ac4be	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214805 application number: ANDA214805

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4550K0SC9B	SODIUM ACETATE	6131-90-4	SODIUM ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69784-231-20	69784023120	100 mL in 1 VIAL, PHARMACY BULK PACKAGE (69784-231-20)	100 ml	2021-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SODIUM ACETATE Injection, USP	Woodward Pharma Services LLC \| MILLA PHARMACEUTICALS, INC. \| S.M. FARMACEUTICI SRL	2023-11-01	HUMAN PRESCRIPTION DRUG LABEL	6