Home NDC 70069-047 Sodium acetate anhydrous
Product NDC 70069-047
11-digit product format 700690047
Labeler code 70069
Product ID 70069-047_1aae3237-9555-442b-b962-619d23f7e00a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium acetate anhydrous
Dosage form SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Somerset Therapeutics, LLC
Application ANDA219826
Marketing category ANDA
Marketing start 2025-10-23
Substance SODIUM ACETATE ANHYDROUS
Active strength 164 mg/mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219826-001 SODIUM ACETATE SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-09-18 A219826-002 SODIUM ACETATE SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-09-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-02-19 14:30 UTC 2026-02 A219826-001 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219826-002 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219826-001 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219826-002 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-09-18 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219826-001 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-09-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219826-002 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2025-09-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sodium acetate anhydrous
Listing expiration 2026-12-31 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 237371 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 70069-047-25 Sodium acetate anhydrous 50 mL in 1 VIAL, GLASS SOLUTION, CONCENTRATE 50 4 70069-047-25 Sodium acetate anhydrous 25 in 1 CARTON SOLUTION, CONCENTRATE 25 4
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 Marketing start Sample Exclude flag Status 70069-047-25 70069004725 25 VIAL, GLASS in 1 CARTON (70069-047-25) / 50 mL in 1 VIAL, GLASS 2025-10-23 No No Current