| Product NDC: | 50383-795 |
| Proprietary Name: | Lactulose |
| Non Proprietary Name: | Lactulose |
| Active Ingredient(s): | 10 g/15mL & nbsp; Lactulose |
| Administration Route(s): | ORAL; RECTAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50383-795 |
| Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA074077 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19950703 |
| Package NDC: | 50383-795-64 |
| Package Description: | 1893 mL in 1 BOTTLE (50383-795-64) |
| NDC Code | 50383-795-64 |
| Proprietary Name | Lactulose |
| Package Description | 1893 mL in 1 BOTTLE (50383-795-64) |
| Product NDC | 50383-795 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Lactulose |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL; RECTAL |
| Start Marketing Date | 19950703 |
| Marketing Category Name | ANDA |
| Labeler Name | Hi-Tech Pharmacal Co., 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] |