Home NDC 63323-032 SODIUM ACETATE
Product NDC 63323-032
11-digit product format 633230032
Labeler code 63323
Product ID 63323-032_37c19fc5-c1ce-4ea0-9cba-4cdf32112091
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM ACETATE
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA206687
Marketing category ANDA
Marketing start 2017-10-30
Substance SODIUM ACETATE
Active strength 4 meq/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing 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 A206687-001 SODIUM ACETATE SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206687-001 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 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206687-001 SODIUM ACETATE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP RS 2017-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION AP 2017-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION AP 2017-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION AP 2017-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION AP 2017-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION AP 2017-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206687-001 SODIUM ACETATE 4MEQ/ML INJECTABLE / INJECTION 2017-10-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base SODIUM ACETATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM ACETATE 4 meq/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4550K0SC9B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312965 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-032-00 SODIUM ACETATE 20 in 1 TRAY INJECTION, SOLUTION, CONCENTRATE 20 6 63323-032-04 SODIUM ACETATE 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, SOLUTION, CONCENTRATE 100 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM ACETATE ACTIVE INGREDIENT 4550K0SC9B SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC] 1 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC] 1 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-032 SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241017_d7fabf08-d4e0-4bb5-8416-2e8ffe27c04b.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-032-00 63323003200 20 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-032-00) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-032-04) 2017-10-30 0000-00-00 No No Current 63323-032-04 63323003204 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 100 ml Historical