Acid Reducer Complete

Product NDC
37012-009
11-digit product format
370120009
Labeler code
37012
Product ID
37012-009_afbd5458-04a6-4f73-9ad2-94cd08fd9677
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine, Calcium Carbonate, Magnesium Hydroxide
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC
Application
ANDA077355
Marketing category
ANDA
Marketing start
2016-01-12
Marketing end
0000-00-00
Substance
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Active strength
800 mg/1; mg/1; mg/1
Pharmacologic classes
Calculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37012-009-713701200097150 TABLET, CHEWABLE in 1 BOTTLE (37012-009-71) 2016-01-120000-00-00NoNoCurrent