| Product NDC: | 0178-0101 |
| Proprietary Name: | Binosto |
| Non Proprietary Name: | alendronate sodium |
| Active Ingredient(s): | 70 mg/1 & nbsp; alendronate sodium |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, EFFERVESCENT |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0178-0101 |
| Labeler Name: | Mission Pharmacal Company |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA202344 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120903 |
| Package NDC: | 0178-0101-01 |
| Package Description: | 1 TABLET, EFFERVESCENT in 1 CARTON (0178-0101-01) |
| NDC Code | 0178-0101-01 |
| Proprietary Name | Binosto |
| Package Description | 1 TABLET, EFFERVESCENT in 1 CARTON (0178-0101-01) |
| Product NDC | 0178-0101 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | alendronate sodium |
| Dosage Form Name | TABLET, EFFERVESCENT |
| Route Name | ORAL |
| Start Marketing Date | 20120903 |
| Marketing Category Name | NDA |
| Labeler Name | Mission Pharmacal Company |
| Substance Name | ALENDRONATE SODIUM |
| Strength Number | 70 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] |