Kristalose is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Cumberland Pharmaceuticals Inc.. The primary component is Lactulose.
| Product ID | 66220-729_22d5911b-d3d5-464d-a7ae-a01fc51defb1 | 
| NDC | 66220-729 | 
| Product Type | Human Prescription Drug | 
| Proprietary Name | Kristalose | 
| Generic Name | Lactulose | 
| Dosage Form | Powder, For Solution | 
| Route of Administration | ORAL | 
| Marketing Start Date | 2012-01-20 | 
| Marketing Category | ANDA / ANDA | 
| Application Number | ANDA074712 | 
| Labeler Name | Cumberland Pharmaceuticals Inc. | 
| Substance Name | LACTULOSE | 
| Active Ingredient Strength | 20 g/20g | 
| 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 | 2012-01-20 | 
| NDC Exclude Flag | N | 
| Sample Package? | N | 
| Marketing Category | ANDA | 
| Application Number | ANDA074712 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Billing Unit | EA | 
| Marketing Start Date | 2012-01-20 | 
| Marketing Category | ANDA | 
| Application Number | ANDA074712 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Billing Unit | EA | 
| Marketing Start Date | 2012-01-20 | 
| Ingredient | Strength | 
|---|---|
| LACTULOSE | 20 g/20g | 
| SPL SET ID: | 535dd1ea-b567-49f7-9a84-8ea91e78c466 | 
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code | 
| NDC | Brand Name | Generic Name | 
|---|---|---|
| 66220-719 | Kristalose | Kristalose | 
| 66220-729 | Kristalose | Kristalose | 
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  KRISTALOSE  86448618  4811363 Live/Registered | Cumberland Pharmaceuticals Inc. 2014-11-07 | 
|  KRISTALOSE  75767058  2439494 Live/Registered | CUMBERLAND PHARMACEUTICALS INC. 1999-08-03 | 
|  KRISTALOSE  75366450  not registered Dead/Abandoned | Bertek Pharmaceuticals Inc. 1997-10-01 |