Sodium Acetate

Product NDC
0641-6263
11-digit product format
006416263
Labeler code
0641
Product ID
0641-6263_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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
NVG71ZZ7P0SODIUM ACETATE ANHYDROUS127-09-3SODIUM ACETATE ANHYDROUS
4550K0SC9BSODIUM ACETATE6131-90-4Sodium Acetate

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6263-100064162631010 VIAL in 1 CARTON (0641-6263-10) / 100 mL in 1 VIAL (0641-6263-01) 10 vial2024-05-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SODIUM ACETATE Injection, USP 2 mEq/mLHikma Pharmaceuticals USA Inc.2024-05-08HUMAN PRESCRIPTION DRUG LABEL1