Lactulose is a Oral; Rectal Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Austria Gmbh. The primary component is Lactulose.
| Product ID | 18124-002_9b0059c3-875c-2ccc-e053-2995a90ad4b8 |
| NDC | 18124-002 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Lactulose |
| Generic Name | Lactulose |
| Dosage Form | Solution |
| Route of Administration | ORAL; RECTAL |
| Marketing Start Date | 2012-12-10 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA090502 |
| Labeler Name | Fresenius Kabi Austria GmbH |
| Substance Name | LACTULOSE |
| Active Ingredient Strength | 10 g/15mL |
| Pharm Classes | Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2012-12-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA090502 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-12-10 |
| Ingredient | Strength |
|---|---|
| LACTULOSE | 10 g/15mL |
| SPL SET ID: | a89835c9-8ce5-4627-8d7d-70ff175b2e07 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0116-4005 | Lactulose | Lactulose |
| 0121-0577 | LACTULOSE | LACTULOSE |
| 0121-0873 | LACTULOSE | Lactulose |
| 0121-1154 | LACTULOSE | LACTULOSE |
| 0121-1746 | LACTULOSE | LACTULOSE |
| 0121-4577 | LACTULOSE | LACTULOSE |
| 0527-5120 | LACTULOSE | LACTULOSE |
| 0527-5125 | LACTULOSE | LACTULOSE |
| 0603-1378 | Lactulose | lactulose |
| 13668-574 | Lactulose | Lactulose |
| 13668-580 | Lactulose | Lactulose |
| 68071-1562 | LACTULOSE | LACTULOSE |
| 69067-010 | Lactulose | Lactulose |
| 17856-1378 | Lactulose | Lactulose |
| 18124-001 | Lactulose | Lactulose |
| 18124-002 | Lactulose | Lactulose |
| 21695-997 | Lactulose | Lactulose |
| 35356-754 | Lactulose | Lactulose |
| 50090-0679 | Lactulose | Lactulose |
| 50090-3381 | Lactulose | Lactulose |
| 50436-3101 | Lactulose | Lactulose |
| 50383-795 | Lactulose | Lactulose |
| 50383-779 | Lactulose | Lactulose |
| 53217-009 | Lactulose | Lactulose |
| 55154-5775 | LACTULOSE | LACTULOSE |
| 55154-9448 | LACTULOSE | LACTULOSE |
| 59741-249 | Lactulose | Lactulose |
| 60432-037 | Lactulose | Lactulose |
| 66689-039 | LACTULOSE | LACTULOSE |
| 66689-038 | LACTULOSE | LACTULOSE |
| 49999-800 | Lactulose | Lactulose |
| 62135-003 | Lactulose | Lactulose |