Home NDC 71357-007 Sodium Acetate
Product NDC 71357-007
11-digit product format 713570007
Labeler code 71357
Product ID 71357-007_47d8d0e7-6db5-950d-e063-6294a90ab1bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Acetate
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler MILLA PHARMACEUTICALS INC.
Application ANDA214805
Marketing category ANDA
Marketing start 2024-10-25
Substance SODIUM ACETATE
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 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# 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 164 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237371 Internal RxNorm lookup 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 71357-007-01 Sodium Acetate 50 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, SOLUTION, CONCENTRATE 50 4 71357-007-10 Sodium Acetate 10 in 1 CASE INJECTION, SOLUTION, CONCENTRATE 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71357-007 SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE SODIUM ACETATE (SODIUM ACETATE INJECTION, USP, 200 MEQ/100 ML) INJECTION, SOLUTION, CONCENTRATE SODIUM ACETATE (SODIUM ACETATE INJECTION, USP, 400 MEQ/100 ML) INJECTION, SOLUTION, CONCENTRATE [MILLA PHARMACEUTICALS INC.] 3 Current NDC, 2 package rows 20241213_1ea1466d-a492-4056-e063-6394a90a80bf.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71357-007-01 71357000701 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 50 ml Historical 71357-007-10 71357000710 10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (71357-007-10) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (71357-007-01) 2024-10-25 No No Current