Lactulose - 0054-3486-63 - (Lactulose)

Alphabetical Index


Drug Information of Lactulose

Product NDC: 0054-3486
Proprietary Name: Lactulose
Non Proprietary Name: Lactulose
Active Ingredient(s): 10    g/15mL & nbsp;   Lactulose
Administration Route(s): ORAL
Dosage Form(s): SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Lactulose

Product NDC: 0054-3486
Labeler Name: Roxane Laboratories, Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA073591
Marketing Category: ANDA
Start Marketing Date: 19920529

Package Information of Lactulose

Package NDC: 0054-3486-63
Package Description: 500 mL in 1 BOTTLE, PLASTIC (0054-3486-63)

NDC Information of Lactulose

NDC Code 0054-3486-63
Proprietary Name Lactulose
Package Description 500 mL in 1 BOTTLE, PLASTIC (0054-3486-63)
Product NDC 0054-3486
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Lactulose
Dosage Form Name SOLUTION
Route Name ORAL
Start Marketing Date 19920529
Marketing Category Name ANDA
Labeler Name Roxane Laboratories, Inc
Substance Name LACTULOSE
Strength Number 10
Strength Unit g/15mL
Pharmaceutical Classes Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Complete Information of Lactulose


General Information