Fluvastatin
- Product NDC
- 63629-8812
- 11-digit product format
- 636298812
- Labeler code
- 63629
- Product ID
- 63629-8812_a94b896f-6170-4ada-970d-9e1e130c7eab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluvastatin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078407
- Marketing category
- ANDA
- Marketing start
- 2012-07-05
- Substance
- FLUVASTATIN SODIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluvastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUVASTATIN SODIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PYF7O1FV7F |
| Rxcui | 310404 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8812-1 | Fluvastatin | 100 in 1 BOTTLE | CAPSULE | 100 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8812 | FLUVASTATIN CAPSULE [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 1 package rows | 20240113_f5e8d1da-8911-42db-9f90-cba04b28d011.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8812-1 | 63629881201 | 100 CAPSULE in 1 BOTTLE (63629-8812-1) | 100 capsule | 2021-09-10 | 0000-00-00 | No | No | Current |