Home NDC 80830-2435 Sodium Acetate
Product NDC 80830-2435
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 RLD / RS 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.
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 RLD / RS 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# 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.
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.
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