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