Home NDC 69784-231 SODIUM ACETATE
Product NDC 69784-231
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 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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69784-231-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69784-231-20 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69784-231-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69784-231-20 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69784-231-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69784-231-20 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69784-231-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69784-231-20 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69784-231-10 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69784-231-20 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69784-231-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69784-231-20 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69784-231-10 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69784-231-20 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69784-231-10 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69784-231-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69784-231-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69784-231-20 D Discontinued by firm 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 RLD / RS 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.
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 RLD / RS 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.
Observed Orange Book exclusivity history# FDA-Initiated Inactive NDC Indexing# 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.
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