| Product NDC: | 49230-643 |
| Proprietary Name: | Phoslyra |
| Non Proprietary Name: | calcium acetate oral solution |
| Active Ingredient(s): | 667 mg/5mL & nbsp; calcium acetate oral solution |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 49230-643 |
| Labeler Name: | Fresenius Medical Care North America |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022581 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110415 |
| Package NDC: | 49230-643-31 |
| Package Description: | 1 BOTTLE in 1 CARTON (49230-643-31) > 473 mL in 1 BOTTLE |
| NDC Code | 49230-643-31 |
| Proprietary Name | Phoslyra |
| Package Description | 1 BOTTLE in 1 CARTON (49230-643-31) > 473 mL in 1 BOTTLE |
| Product NDC | 49230-643 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | calcium acetate oral solution |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20110415 |
| Marketing Category Name | NDA |
| Labeler Name | Fresenius Medical Care North America |
| Substance Name | CALCIUM ACETATE |
| Strength Number | 667 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] |