Sodium Acetate

Product NDC: 80830-2435
Requested package NDC: 80830-2435-2
11-digit product format: 808302435
Labeler code: 80830
Product ID: 80830-2435_0006a5e7-aedf-40a7-9d69-c290ec63ffaa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Acetate
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Amneal Pharmaceuticals Private Limited
Application: ANDA218469
Marketing category: ANDA
Marketing start: 2026-03-03
Substance: SODIUM ACETATE ANHYDROUS
Active strength: 164 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A218469-001	SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08
A218469-002	SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08
A218469-003	SODIUM ACETATE	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2026-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218469-001	AP
A218469-002	AP
A218469-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218469-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218469-002	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218469-003	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2026-03-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218469-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218469-002	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218469-003	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2026-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218469-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218469-002	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218469-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218469-002	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218469-001	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218469-002	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2025-08-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218469-003	SODIUM ACETATE	40MEQ/20ML (2MEQ/ML)	SOLUTION / INTRAVENOUS	AP	2026-03-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218469-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218469-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218469-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218469-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218469-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218469-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218469-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218469-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218469-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218469-002	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218469-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218469-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218469-003	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Sodium Acetate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM ACETATE ANHYDROUS	164 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NVG71ZZ7P0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1859490	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0c0b11da-d7fc-4b4c-b0ef-d97af8e88abf	Available on FDA.report

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	Amneal Pharmaceuticals Private Limited	0c0b11da-d7fc-4b4c-b0ef-d97af8e88abf	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218469 application number: ANDA218469 ndc (package): 80830-2435-2 ndc (product): 80830-2435 ndc11 (package): 80830243502
SODIUM ACETATE	SODIUM ACETATE	Amneal Pharmaceuticals Private Limited	338105c0-c645-4b84-a125-4e1ead92b840	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218469 application number: ANDA218469

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NVG71ZZ7P0	SODIUM ACETATE ANHYDROUS	127-09-3	SODIUM ACETATE ANHYDROUS
4550K0SC9B	SODIUM ACETATE	6131-90-4	Sodium Acetate

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80830-2435-2	80830243502	25 BOTTLE, PLASTIC in 1 CARTON (80830-2435-2) / 20 mL in 1 BOTTLE, PLASTIC (80830-2435-1)	2026-03-03	No	No	Current