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 |