Home NDC 0641-6262 Sodium Acetate
Product NDC 0641-6262
11-digit product format 006416262
Labeler code 0641
Product ID 0641-6262_777b7564-f07b-401a-a042-0cd512ae3b25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Acetate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA216920
Marketing category ANDA
Marketing start 2024-05-20
Substance SODIUM ACETATE ANHYDROUS
Active strength 164 mg/mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216920-001 SODIUM ACETATE SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 A216920-002 SODIUM ACETATE SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 A216920-003 SODIUM ACETATE SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15
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.
Product history page 1 of 2 · 45 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 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216920-002 SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216920-003 SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216920-001 SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION / INTRAVENOUS AP 2024-03-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216920-001 CGT 2024-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216920-001 CGT 2024-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216920-001 CGT 2024-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216920-001 CGT 2024-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216920-001 CGT 2024-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216920-001 CGT 2024-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216920-001 CGT 2024-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216920-001 CGT 2024-11-16 1e350fbaab3a…
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 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 0641-6262-01 Sodium Acetate 1 in 1 CARTON INJECTION 1 1 0641-6262-01 Sodium Acetate 50 mL in 1 VIAL INJECTION 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6262 SODIUM ACETATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 1 Current NDC, 2 package rows 20240520_7ee23a1c-bc99-4ff6-b2e7-d2aa42744553.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 0641-6262-01 00641626201 1 VIAL in 1 CARTON (0641-6262-01) / 50 mL in 1 VIAL 1 vial 2024-05-20 No No Current