| Product NDC: | 53113-105 |
| Proprietary Name: | Gadavyt Enema |
| Non Proprietary Name: | dibasic sodium phosphate, monobasic sodium phosphate |
| Active Ingredient(s): | 3.5; 9.5 g/59mL; g/59mL & nbsp; dibasic sodium phosphate, monobasic sodium phosphate |
| Administration Route(s): | RECTAL |
| Dosage Form(s): | LIQUID |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 53113-105 |
| Labeler Name: | Gadal Laboratories Inc |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | part334 |
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Start Marketing Date: | 20121001 |
| Package NDC: | 53113-105-66 |
| Package Description: | 66 mL in 1 BOTTLE, WITH APPLICATOR (53113-105-66) |
| NDC Code | 53113-105-66 |
| Proprietary Name | Gadavyt Enema |
| Package Description | 66 mL in 1 BOTTLE, WITH APPLICATOR (53113-105-66) |
| Product NDC | 53113-105 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | dibasic sodium phosphate, monobasic sodium phosphate |
| Dosage Form Name | LIQUID |
| Route Name | RECTAL |
| Start Marketing Date | 20121001 |
| Marketing Category Name | OTC MONOGRAPH NOT FINAL |
| Labeler Name | Gadal Laboratories Inc |
| Substance Name | SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC |
| Strength Number | 3.5; 9.5 |
| Strength Unit | g/59mL; g/59mL |
| Pharmaceutical Classes |