FLUVASTATIN SODIUM ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Fluvastatin Sodium.
| Product ID | 0781-5370_c184692f-4afa-47b9-80d3-481fde50a4fa |
| NDC | 0781-5370 |
| Product Type | Human Prescription Drug |
| Proprietary Name | FLUVASTATIN SODIUM ER |
| Generic Name | Fluvastatin Sodium |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-10-16 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA021192 |
| Labeler Name | Sandoz Inc |
| Substance Name | FLUVASTATIN SODIUM |
| Active Ingredient Strength | 80 mg/1 |
| Pharm Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2015-10-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA authorized generic |
| Application Number | NDA021192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-10-16 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | NDA authorized generic |
| Application Number | NDA021192 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-10-16 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| FLUVASTATIN SODIUM | 80 mg/1 |
| SPL SET ID: | dde8cf19-866e-4884-b582-de2730c7524e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-7446 | Fluvastatin Sodium | Fluvastatin Sodium |
| 0527-2580 | Fluvastatin Sodium | Fluvastatin Sodium |
| 0781-5370 | FLUVASTATIN SODIUM | fluvastatin sodium |
| 0781-8017 | FLUVASTATIN SODIUM | fluvastatin sodium |
| 0078-0354 | Lescol | fluvastatin sodium |
| 68151-4471 | Lescol | fluvastatin sodium |