| Product NDC: | 49999-800 | 
| 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: | 49999-800 | 
| Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA074623 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20040419 | 
| Package NDC: | 49999-800-32 | 
| Package Description: | 946 mL in 1 BOTTLE (49999-800-32) | 
| NDC Code | 49999-800-32 | 
| Proprietary Name | Lactulose | 
| Package Description | 946 mL in 1 BOTTLE (49999-800-32) | 
| Product NDC | 49999-800 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | lactulose | 
| Dosage Form Name | SOLUTION | 
| Route Name | ORAL | 
| Start Marketing Date | 20040419 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 
| 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] |