| Product NDC: | 66621-4000 |
| Proprietary Name: | Cystadane |
| Non Proprietary Name: | betaine |
| Active Ingredient(s): | 6 g/1 & nbsp; betaine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | POWDER, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 66621-4000 |
| Labeler Name: | Rare Disease Therapeutics, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020576 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19961025 |
| Package NDC: | 66621-4000-1 |
| Package Description: | 180 POWDER, FOR SOLUTION in 1 BOTTLE (66621-4000-1) |
| NDC Code | 66621-4000-1 |
| Proprietary Name | Cystadane |
| Package Description | 180 POWDER, FOR SOLUTION in 1 BOTTLE (66621-4000-1) |
| Product NDC | 66621-4000 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | betaine |
| Dosage Form Name | POWDER, FOR SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 19961025 |
| Marketing Category Name | NDA |
| Labeler Name | Rare Disease Therapeutics, Inc. |
| Substance Name | BETAINE |
| Strength Number | 6 |
| Strength Unit | g/1 |
| Pharmaceutical Classes | Methylating Activity [MoA],Methylating Agent [EPC] |