SODIUM BICARBONATE

Product NDC
52584-096
11-digit product format
525840096
Labeler code
52584
Product ID
52584-096_0f0d471b-7a06-4c7e-a740-bf531a3655af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium bicarbonate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc.
Application
ANDA202981
Marketing category
ANDA
Marketing start
2019-11-11
Marketing end
2024-02-01
Substance
SODIUM BICARBONATE
Active strength
42 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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-096-12525840096121 VIAL, SINGLE-USE in 1 BAG (52584-096-12) > 5 mL in 1 VIAL, SINGLE-USE2019-11-112024-02-01NoNoCurrent